Acupuncture for (sub)acute non-specific low ... - Wiley Online Library

Cochrane Database of Systematic Reviews

Acupuncture for (sub)acute non-specific low-back pain (Protocol) Furlan AD, Yazdi F, Tsertsvadze A, Lao L, Sherman K, Ammendolia C, Wang E, Shin BC, Wakayama I, van Tulder MW

Furlan AD, Yazdi F, Tsertsvadze A, Lao L, Sherman K, Ammendolia C, Wang E, Shin BC, Wakayama I, van Tulder MW. Acupuncture for (sub)acute non-specific low-back pain. Cochrane Database of Systematic Reviews 2011, Issue 8. Art. No.: CD009265. DOI: 10.1002/14651858.CD009265.

www.cochranelibrary.com

Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . ACKNOWLEDGEMENTS . . . REFERENCES . . . . . . . . APPENDICES . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . SOURCES OF SUPPORT . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .


. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

. . . . . . . . . . .

1 1 1 2 2 6 6 7 37 37 37

i

[Intervention Protocol]

Acupuncture for (sub)acute non-specific low-back pain Andrea D Furlan1 , Fatemeh Yazdi2 , Alexander Tsertsvadze3 , Lixing Lao4 , Karen Sherman5 , Carlo Ammendolia1 , Ellen Wang6 , ByungCheul Shin7 , Ikuro Wakayama8 , Maurits W van Tulder9 1 Institute for Work & Health, Toronto, Canada. 2 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), Ottawa, Canada. 3 University of Ottawa Evidence-Based Practice Center, Clinical Epidemiology Methods Centre, Ottawa Hospital Research Institute, Ottawa, Canada. 4 Complementary Medicine Program, University of Maryland School of Medicine, Baltimore, Maryland, USA. 5 Group Health Center for Health Studies, Seattle, WA, USA. 6 Rehabilitation Studies Unit, Faculty of Medicine, University of Sydney, Sydney, Australia. 7 Rehabilitation Medicine, School of Korean Medicine, Pusan N. University, Korea, Yangsan, Korea, South. 8 Kansai University of Health Sciences, Kumatori, Japan. 9 Department of Health Sciences, Faculty of Earth and Life Sciences, VU University, Amsterdam, Netherlands

Contact address: Andrea D Furlan, Institute for Work & Health, 481 University Avenue, Suite 800, Toronto, ON, M5G 2E9, Canada. [email protected]. Editorial group: Cochrane Back and Neck Group. Publication status and date: New, published in Issue 8, 2011. Citation: Furlan AD, Yazdi F, Tsertsvadze A, Lao L, Sherman K, Ammendolia C, Wang E, Shin BC, Wakayama I, van Tulder MW. Acupuncture for (sub)acute non-specific low-back pain. Cochrane Database of Systematic Reviews 2011, Issue 8. Art. No.: CD009265. DOI: 10.1002/14651858.CD009265. Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: The objectives of this systematic review are to determine the effects of acupuncture for (sub)acute non-specific low-back pain compared to no treatment, placebo/sham acupuncture or other sham procedures, other therapies, the addition of acupuncture to other therapies, and between various techniques of acupuncture.

BACKGROUND

quently, the therapeutic management of (sub) acute low-back pain varies widely.

Description of the condition

Description of the intervention

Low-back pain is a major health problem among western industrialized countries, and a major cause of medical expenses, absenteeism and disablement (Deyo 2006). Although low-back pain is usually a self-limiting and benign disease (Waddell 1987), a large variety of therapeutic interventions are available to treat it (Haldeman 2008). However, the effectiveness of most of these interventions has not been convincingly demonstrated and conse-

Acupuncture is one of the oldest forms of therapy and has its roots in ancient Chinese philosophy. Traditional acupuncture is based on a number of philosophical concepts, one of which postulates that any manifestation of disease is considered a sign of imbalance between the Yin and Yang forces within the body. In classical acupuncture theory, it is believed that all disorders are reflected at specific points, either on the skin surface or just below it. Vital en-


1

ergy (qi) circulates throughout the body along the so-called meridians, which have either Yin or Yang characteristics. An appropriate choice of the 361 classical acupuncture points located on these twelve meridians for needling is believed to restore the balance in the body. When the needles have been placed successfully, the patient is supposed to experience a sensation known as de qi (in some schools of traditional acupuncture). De qi has been defined as a subjective feeling of fullness, numbness, tingling, and warmth, with some local soreness and a feeling of distension around the acupuncture point. There is no consensus among acupuncturists about the necessity of reaching de qi for acupuncture to be effective (Hui 2007). Since acupuncture disseminated to the west several hundred years ago, many different styles of acupuncture have evolved, including Japanese Meridian Therapy, French Energetic Acupuncture, Korean Constitutional Acupuncture and Lemington Five Element Acupuncture. While these are similar to traditional acupuncture, they each have distinct characteristics. In recent decades, acupuncture has expanded to include micro-system acupuncture such as ear (auricular) acupuncture, scalp (head) acupuncture, hand acupuncture, and foot acupuncture (Lao 1996). Modern acupuncturists use not only traditional meridian acupuncture points, but also non-meridian or extra-meridian acupuncture points, which are fixed points that are not necessarily associated with meridians. Acupuncture commonly includes manual stimulation of the needles, but various adjuncts are often used, including electroacupuncture (in which an electrical stimulator is connected to the acupuncture needle), injection acupuncture (herbal extracts injected into acupuncture points), heat lamps, and acupuncture with moxibustion (the moxa herb, Artemisia vulgaris, is burned at the handle of the needle for heat stimulation) (Lao 1996).

How the intervention might work It is still unclear what exact mechanisms underlie the action of acupuncture. Western scientific research has proposed mechanisms for the effect of acupuncture on pain relief. It has been suggested that the action of acupuncture might follow the principles of the gate control theory of pain. One type of sensory input (lowback pain) could be inhibited in the central nervous system by another type of input (needling). Another theory, the diffuse noxious inhibitory control (DNIC) (White 2006), implies that noxious stimulation of heterotopic body areas modulates the pain sensation originating in areas where a subject feels pain. There is also some evidence that acupuncture may stimulate the production of endorphins, serotonin and acetylcholine within the central nervous system, enhancing analgesia (Stux 2003). Other theories of acupuncture analgesia are based on neuromodulation of the central nervous system (Audette 2004). These are supported by human brain f-MRI studies (Hui 2010). A recent systematic review of the physiological rational of acupuncture identified 76 clinical trials. Among these, 33 proposed a neurochemical mechanism; two,

segmental nervous system effects; six, autonomic nervous system regulation; three, local effects; five, effects on brain function; and five, other effects (Moffet 2006). It has also been suggested that both specific and non-specific factors may play a role in the effectiveness of acupuncture (Liu 2009). Needle insertion into specific sites on the body acts on expectation mechanisms via attentional mechanisms, thus working through potentiation and modulation of expectation activated opioid systems (Liu 2009).

Why it is important to do this review The effectiveness of acupuncture in the treatment of (sub)acute low-back pain has been systematically reviewed before (van Tulder 1999; van Tulder 1999a; Furlan 2005; Furlan 2005a) with inconclusive results due to the paucity and high risk of bias of the included studies. Due to the increasing number of studies of acupuncture for various types of back pain, we have decided to present results in separate reviews for three types of back pain: acute non-specific back pain, chronic non-specific back pain (Sherman 2011), and back pain attributed to underlying presumptive etiology (Ammendolia 2011). This is an updated review of all available scientific evidence, including evidence from Chinese, Korean and Japanese trials, on the effectiveness of acupuncture for (sub) acute non-specific low-back pain.

OBJECTIVES The objectives of this systematic review are to determine the effects of acupuncture for (sub)acute non-specific low-back pain compared to no treatment, placebo/sham acupuncture or other sham procedures, other therapies, the addition of acupuncture to other therapies, and between various techniques of acupuncture.

METHODS

Criteria for considering studies for this review

Types of studies We will follow the methodology recommended in the Cochrane handbook (Higgins 2011) and by the Cochrane Back Review Group (Furlan 2009). We will only include randomised controlled trials (RCTs), with no language restriction, in this Cochrane systematic review.


2

Types of participants We will include adults (>18 years) with (sub)acute non-specific low-back pain. (Sub)acute is defined as pain duration less than 12 weeks. We will exclude studies that include a mixed population with (sub)acute and chronic non-specific low-back pain where the results of acupuncture for (sub)acute pain cannot be extracted separately. When the duration of low-back pain is not reported in the manuscript, we will attempt to contact the authors to obtain more information, but if we cannot obtain the response, we will exclude the study. Although some studies do not exclusively limit the study population to patients with non-specific symptoms, we will include studies if the majority (>50%) of the patients had non-specific low-back pain according to the predefined criteria. We will exclude RCTs that included subjects with low-back pain caused by specific etiological entities such as infection, metastatic diseases, neoplasm, osteoarthritis, rheumatoid arthritis or fractures. We will also exclude low-back pain during pregnancy and post-partum. Chronic non-specific low-back pain (Sherman 2011) and lowback pain attributed to underlying presumptive etiology ( Ammendolia 2011) will be the subjects of two other Cochrane Reviews conducted for the Cochrane Back Review Group. Types of interventions In this review, we will include articles that evaluate acupuncture treatments that involve needling. Articles that involve dryneedling for low-back pain attributed to myofascial pain syndrome will be included in another Cochrane review of low-back pain attributed to an underlying presumptive etiology (Ammendolia 2011). We will include studies in which “the diagnosis was made using traditional acupuncture theory and the needles were inserted in classical meridian points, ear points, extra points or Ah-shi points (painful points)’, Regardless of the source of stimulation (e.g., manual, heat by moxa or electrical stimulation). We will exclude studies in which the acupuncture treatment did not involve needling, such as acupressure or laser acupuncture. The control interventions will be: no treatment, placebo/sham acupuncture or other sham procedures, and other therapeutic interventions. We will also include trials which test the effectiveness of acupuncture as an adjunct treatment to other therapies compared to other therapies and trials comparing two techniques of acupuncture. Types of outcome measures We will include RCTs that used at least one of the four outcome measures considered to be important in the field of low-back pain: 1. pain intensity (e.g., visual analogue scale (VAS)) 2. back-specific functional status (e.g., Roland Morris Disability Scale, Oswestry Disability Scale) 3. global measure of improvement or recovery (e.g., overall improvement, proportion of patients recovered, subjective improvement of symptoms)

4. work-relevant outcomes (e.g., return-to-work status, number of days off work, productivity, etc).

Primary outcomes

The primary outcomes for this review will be pain and back-specific functional status.

Secondary outcomes

Secondary outcomes will be global measures of improvement, work-relevant outcomes, and complications

Search methods for identification of studies In the previous review (Furlan 2005), we updated the literature from 1966 until February 2003 using the following databases and strategies: 1. CENTRAL, (The Cochrane Library, 2003, issue 1); 2. MEDLINE (OVID) (see Appendix 1 for strategy); 3. EMBASE (OVID) (see Appendix 2 for strategy); 4. The Chinese Cochrane Centre Trials Registry (in February 2003); 5. A database search of controlled clinical trials published in Japan, using ”Igaku Chuo Zasshi“ (Japana Centra Revuo Medicina) web version (between 1987 - February 2003); 7. Reference lists in review articles and trials retrieved; and 8. Personal communication with experts in the field. Electronic searches For this updated review, we will use the following strategies. 1. Researchers at the University of Ottawa - Evidence-based Practice Centre (UO-EPC) updated the literature searches to February 2010 as part of the CAM BACK II report for the NCCAM (NIH) (Furlan 2010): • Electronic search strategies were developed and tested through an iterative process by an experienced medical information specialist in consultation with the UO-EPC team. • The following databases were searched: MEDLINE; the Cochrane Library including CENTRAL, Cochrane Database of Systematic Reviews, DARE, HTA, NHSEED; EMBASE; CINAHL; AMED; and EBM Reviews ACP Journal Club. Specialized CAM databases were also searched, including the Index to Chiropractic Literature (ILC); Acubriefs; Complementary and Alternative Medicine (NZ); and the LILACS Database. Several of these databases provided extensive coverage of foreign (e.g., Asian, South American) language materials. • Strategies utilized a combination of controlled vocabulary and keywords. (See Appendix 3 for full search strategies)


3

• There were no language or date restrictions on any of the searches; animal studies were excluded. • Additional references were also sought through handsearching the bibliographies of relevant items. • Grey (unpublished) literature was identified by searching the websites of relevant specialty societies and organizations, Health Technology Agencies (HTAs), economic research institutions, guideline collections, trial registries, and conferences. (See Appendix 4 for full search strategies) 2. One member of our team (BCS) searched six Korean medical databases for trials published in Korea to March 2010, i.e. DBPIA, Korea Institute of Science and Technology Information, The National Library of Korea, Korean traditional knowledge portal, OASIS and KoreaMed. Another member of our team (IW) will update the searches in the Japanese databases up to the present. 3. The Trials Search Co-ordinator of the Cochrane Back Review Group will search CENTRAL, MEDLINE, EMBASE, and CINAHL, using the search strategies shown in Appendix 1 and Appendix 2 from January 2010 to the present.

Searching other resources We will review reference lists in review articles and trials.

Data collection and analysis

Selection of studies For this updated review, we will use a three-step study selection process: 1) This step has already occurred: The team at Chalmers Institute (FY and AT) generated the electronic search strategies and downloaded the citations into Systematic Review Software (SRS). Two review authors (FY and AT) independently reviewed the information to identify trials that potentially met the inclusion criteria. Full articles describing these trials were obtained and the same two review authors independently applied the selection criteria to the studies. Consensus was used to solve disagreements concerning the final inclusion of RCTs and a third review author was consulted when disagreements persisted. The authors of recent original studies were contacted to obtain more information when needed. 2) One member of our team (BCS) will select the articles meeting inclusion criteria from the searches in the Korean databases, and another member (IW) will select the articles in the Japanese databases. In each case, these review authors will find a second reviewer who will independently assess the studies for inclusion/ exclusion and will discuss to reach consensus. 3) The Back Group Trials Search Co-ordinator will do a preliminary screening of the Titles and Abstracts identified in the other

searches and will send them to the contact author. Two review authors will apply the inclusion criteria and select studies for inclusion in this updated review.

Data extraction and management Two review authors will independently extract the data on the study characteristics, funding, ethics, study population, interventions, analyses and outcomes. The team at Chalmers Institute used SRS (Systematic Reviews Software, TrialStaT) for this purpose. Our team will use Microsoft Excel for data extraction. We will contact the authors of recent studies (published in the past five years) to obtain more information when needed.

Adequacy of treatment

BCS, IW and an acupuncturist supervised by LXL will judge the adequacy of treatment using the STRICTA recommendations (MacPherson 2010): 1) Choice of acupoints, 2) Number of sessions, 3) Needling technique and 4) Acupuncturist experience. The control groups will also be judged for 1) appropriateness of sham/placebo intervention and 2) adequate number of sessions/ dose. For each of these treatment components, they will rate adequacy on a three-point scale from 1=not at all appropriate to 3= most appropriate.

Assessment of risk of bias in included studies We will use the 12-item criteria list recommended by the Cochrane Back Review Group plus one item “Other Sources of Bias” to assess the risk of bias (Boutron 2005; Furlan 2009; van Tulder 2003; Appendix 5). For each study, we will rate a criterion as ”low risk“, ”high risk“ or ”unclear“ to identify its performance against the criteria and record our decision in the Risk of Bias Table. Each study will be classified as having low or high risk of bias depending on the number of criteria met: studies fulfilling at least six criteria and not having a fatal flaw will be judged as having ‘low risk of bias’. Studies with a fatal flaw, or those meeting fewer than six criteria will be judged as having ‘high risk of bias’. Examples of fatal flaws are 1) an unacceptably high drop-out rate (greater than 50% at the first and subsequent follow-up measurements); 2) an unacceptably low adherence rate; or 3) statistically and clinically-relevant important baseline differences for one or more primary outcomes (i.e. pain, functional status) indicating unsuccessful randomisation.

Measures of treatment effect The primary analyses, decided a priori, will be: • acupuncture compared to no treatment, placebo / sham acupuncture or other sham procedures • acupuncture compared to another intervention


4

• acupuncture added to an intervention compared to the same intervention without acupuncture. We will consider any other comparisons as secondary analysis: • comparison between different acupuncture techniques We will plot the results of each RCT as point estimates, i.e., relative risks (RR) with corresponding 95% confidence interval (CI) for dichotomous outcomes, mean and standard deviation (SD) for continuous outcomes, or other data types as reported by the authors of the studies. When the results cannot be plotted, they will be described in the table of Characteristics of included studies. For continuous measures, we will give preference to analysing the results with mean differences (MD) when the same instruments are used, otherwise, we will use standardized mean differences (SMD) for effect sizes.

Dealing with missing data When there are insufficient data to enter in the meta-analysis (even after contacting the authors), we will report the results qualitatively in the table of Characteristics of Included studies and in the Summary of findings tables. Assessment of heterogeneity We will assess the studies first for clinical homogeneity with respect to the duration of the disorder, types of acupuncture, control group, outcomes measures and timing of follow-up. Clinically heterogeneous studies will be not combined in the analysis, but separately described. For studies judged as clinically homogeneous, we will test statistical heterogeneity with the Q test (Chi-statistic) and I². We will pool clinically and statistically homogeneous studies using the fixed-effect model. We will pool clinically homogeneous and statistically heterogeneous studies using the random-effects model.

Unit of analysis issues We will group the results according to the following study characteristics:

Assessment of reporting biases This is described under assessment of risk of bias (Appendix 5). Data synthesis

1) Control group:

a. no treatment b. placebo or sham acupuncture c. other interventions d. another techniques of acupuncture

2) Outcome measures:

a. Pain b. Global measure c. Back-specific functional status d. Work-relevant outcomes e. Physical examination f. Generic health status, other symptoms, medication use, etc g. Complications

3) Timing of follow-up:

a. immediately after the end of the sessions - up to one week after the end of the sessions b. short-term follow-up - between one week and three months after the end of the sessions c. intermediate-term follow-up - between three months and one year after the end of the sessions d. long-term follow-up - one year or longer after the end of the sessions

We will assess the overall strength of evidence using the grading system approach suggested by the Evidence-based Practice Center (EPC) program of the U.S. Agency for Healthcare Research and Quality (AHRQ) (Owens 2010). This system is largely based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) (Guyatt 2008) working group approach (Atkins 2004) and is similar to the system recommended by the Cochrane Back Review Group (Furlan 2009). The evidence grading method consists of four major domains: 1) risk of bias (aggregate measure of the overall quality or degree of bias of study/studies for a given outcome or comparison). This criteria will be downgraded when >25% of the participants were from studies with a high risk of bias (RoB) 2) consistency (the degree to which results of studies for a given outcome or comparison are uniform in terms of effect direction and statistical significance). Results will be considered consistent when I² < 50%; or in the absence of meta-analysis, all trials show statistically significant or non-significant effects in the same direction. 3) directness (ultimate health outcomes versus surrogate outcomes). Clinical outcomes such as pain and back-specific disability or function will be considered ‘direct evidence’. Other measures, such as quality of life, proportion of subjects who improved, time to (or duration of ) analgesic effect, use of analgesics, utilization of conventional healthcare system (e.g., general practitioner visits, imaging studies), sick leave (e.g., length, proportion of subjects), and proportion of subjects cured will be considered ‘indirect evidence’.


5

4) precision (the degree of variability/uncertainty around the pooled effect estimate). The pooled estimate with relatively narrow range of effect sizes (95% CIs) with clear direction leading to a clinically uniform conclusion will be considered ‘precise evidence’. We will not downgrade the quality of the evidence based on this domain simply due to the absence of meta-analysis because this might not be appropriate and available at all times. In addition, the evidence will be considered imprecise when the total number of participants are less than 400 (continuous outcomes) or 300 (dichotomous outcomes). The overall quality of the evidence for a given outcome will derive from the assessment of the four domains described above. Depending on ratings, the quality of the evidence will be high, moderate, low, or insufficient (Appendix 6). The absence of evidence will be graded as ‘insufficient’. Subgroup analysis and investigation of heterogeneity We do not plan any subgroup analyses for this review.

To determine if there is publication bias, we will construct funnel plots when at least 10 studies are available for the meta-analysis (Sutton 2000).

Sensitivity analysis For the primary outcomes, when we find comparisons that include 10 or more trials with mixed risks of bias (low and high), we will conduct a sensitivity analysis including only trials with a low risk of bias to check if this would change the main conclusions.

ACKNOWLEDGEMENTS The authors of this review would like to thank Vicki Pennick, managing editor of the Cochrane Back Review Group and Rachel Couban, trials search co-ordinator of the Cochrane Back Review Group for their assistance and support.

REFERENCES

Additional references Ammendolia 2011 Ammendolia C, van Tulder MW, Furlan AD, Tsertsvadze A, Wang E, Tsukayama H, Lao L, Yazdi F, Shin B-C. Acupuncture for low back pain attributed to underlying presumptive etiology. Cochrane Database of Systematic Reviews (draft). Atkins 2004 Atkins D, Best D, Briss PA, Eccles M, Falck-Yttr Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ (Clinical research ed.) 2004;328 (7454):1490. Audette 2004 Audette JF, Ryan AH. The role of acupuncture in pain management. Physical Medicine and Rehabilitation Clinics of North America 2004;15(4):749–72. Boutron 2005 Boutron I, Moher D, Tugwell P, Giraudeau B, Poiraudeau S, Nizard R, et al. A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. Journal of Clinical Epidemiololgy 2005;58 (12):1233–40. Deyo 2006 Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. National Surveys, 2002. Spine 2006;31(23):2724–7. Furlan 2009 Furlan AD, Pennick V, Bombardier C, van Tulder M, Editorial Board Cochrane Back Review Group. 2009 updated method guidelines for systematic reviews in

the Cochrane Back Review Group. Spine 2009;34(18): 1929–41. Furlan 2010 Furlan A, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, et al. Complementary and Alternative Therapies for Back Pain II. Evidence Report/Technology Assessment No. 194. (Prepared by the University of Ottawa Evidence-based Practice Center under Contract No. 2902007-10059-I (EPCIII). Report. Rockville, MD: Agency for Healthcare Research and Quality., 2010; Vol. AHRQ Publication No. 10(11) E007. Guyatt 2008 Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ (Clinical Research ed.) 2008;336(7650):924–6. Haldeman 2008 Haldeman S, Dagenais S. What have we learned about the evidence-informed management of chronic low back pain?. The Spine Journal 2008;8(1):266–77. Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. Hui 2007 Hui KK, Nixon EE, Vangel MG, Liu J, Marina O, Napadow V, et al. Characterization of the ”deqi“ response in acupuncture. BioMed Central Complementary and Alternative Medicine 2007;7:33.


6

Hui 2010 Hui KK, Napadow V, Liu J, Li M, Marina O, Nixon EE, et al. Monitoring acupuncture effects on human brain by FMRI. Journal of Visualized Experiments (video article) 2010; Vol. 38:http://www.jove.com/index/Details.stp?ID= 1190. [DOI: 10.3791/1190] Lao 1996 Lao L. Acupuncture techniques and devices. The Journal of Alternative and Complementary Medicine 1996;2:23–5. Liu 2009 Liu T. Acupuncture: what underlies needle administration? . Evidence-Based Complementary and Alternative Medicine 2009;6(2):185–93. MacPherson 2010 MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Public Library of Science Medicine 2010;7(6):e1000261. Moffet 2006 Moffet HH. How might acupuncture work? A systematic review of physiologic rationales from clinical trials. BioMed Central Complementary and Alternative medicine 2006;6 (25). [DOI: 10.1186/1472-6882-6-25] Owens 2010 Owens DK, Lohr KN, Atkins D, Treadwell JR, Reston JT, Bass EB, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions-agency for healthcare research and quality and the effective health-care program. Journal of Clinical Epidemiology 2010; 63(5):513–23. Sherman 2011 Furlan AD, Sherman K, Yazdi F, Tsertsvadze A, Tsukayama H, Lao L, et al. Acupuncture for chronic non-specific lowback pain. Cochrane Database of Systematic Reviews (draft). Stux 2003 Stux G, Berman B, Pomeranz B. Basics of acupuncture. 5th Edition. Berlin Heidelberg: Springer-Verlag, 2003. Sutton 2000 Sutton AJ, Duval SJ, Tweedie RL, Abrams KR, Jones DR. Empirical assessment of effect of publication bias on meta-

analyses. BMJ (Clinical Reserach Ed.) 2000 June 10;320 (7249):1574–7. van Tulder 2003 van Tulder M, Furlan A, Bombardier C, Bouter L, The Editorial Board of the Cochrane Collaboration Back Review Group. Updated method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group. Spine 2003;28(12):1290–9. Waddell 1987 Waddell G. A new clinical model for the treatment of low back pain. Spine 1987;12:632–44. White 2006 White P. A background to acupuncture and its use in chronic painful musculoskeletal conditions. The Journal of the Royal Society for the Promotion of Health. 2006;126(5): 219–27.

References to other published versions of this review Furlan 2005 Furlan AD, van Tulder MW, Cherkin DC, Tsukayama H, Lao L, Koes BW, et al. Acupuncture and dryneedling for low-back pain. Cochrane Database of Systematic Reviews 2005, Issue 1. [DOI: 10.1002/ 14651858.CD001351.pub2] Furlan 2005a Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, et al. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the Cochrane Collaboration. Spine 2005;30(8):944–63. van Tulder 1999 van Tulder MW, Cherkin D, Berman B, Lao L, Koes BW. Acupuncture for low back pain. Cochrane Database of Systematic Reviews 1999, Issue 2. [DOI: 10.1002/ 14651858.CD001351] van Tulder 1999a van Tulder MW, Cherkin DC, Berman B, Lao L, Koes BW. The effectiveness of acupuncture in the management of acute and chronic low back pain. A systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 1999;24(11):1113–23. ∗ Indicates the major publication for the study


7

APPENDICES

Appendix 1. MEDLINE search strategy 1 randomized controlled trial.pt. (72769) 2 controlled clinical trial.pt. (16977) 3 Randomized Controlled Trials/ (17706) 4 Random Allocation/ (11879) 5 Double-Blind Method/ (26902) 6 Single-Blind Method/ (4389) 7 or/1-6 (120640) 8 Animal/ not Human/ (583159) 9 7 not 8 (112795) 10 clinical trial.pt. (144571) 11 exp Clinical Trials/ (45063) 12 ((singl$ or doubl$ or trebl$ or tripl$) adj (mask$ or blind$)).tw. (24652) 13 Placebos/ (4548) 14 placebo$.tw. (30921) 15 random$.tw. (123481) 16 Research Design/ (12824) 17 (latin adj square).tw. (663) 18 (clinic$ adj25 trial$).tw. (43883) 19 or/10-18 (275600) 20 19 not 8 (256926) 21 20 not 9 (147773) 22 Comparative Study/ (298320) 23 exp Evaluation Studies/ (155611) 24 Follow-Up Studies/ (95462) 25 Prospective Studies/ (77754) 26 (control$ or prospective$ or volunteer$).tw. (521438) 27 Cross-Over Studies/ (9791) 28 or/22-27 (917800) 29 28 not 8 (737443) 30 29 not (9 or 21) (559548) 31 9 or 21 or 30 (820116) 32 Intervertebral disk/ (1230) 33 Lumbar vertebrae/ (6673) 34 Low-back pain/ (3418) 35 Sciatica/ (544) 36 low back pain.tw. (2796) 37 backache.tw. (276) 38 lumbago.tw. (174) 39 or/32-38 (11150) 40 ACUPUNCTURE/ (114) 41 exp ACUPUNCTURE ANALGESIA/ (185) 42 exp ACUPUNCTURE, EAR/ (31) 43 exp ACUPUNCTURE POINTS/ (403) 44 exp ACUPUNCTURE THERAPY/ (1918) 45 acupuncture.tw. (1655) 46 electro-acupuncture.tw. (62) 47 acupressure.tw. (84) 48 or/40-47 (2324) Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

8

49 31 and 39 and 48 (49)

Appendix 2. EMBASE, CINAHL and CENTRAL search strategies EMBASE 1 clinical article/ (299265) 2 clinical study/ (2230) 3 clinical trial/ (184343) 4 controlled study/ (953915) 5 randomized controlled trial/ (58211) 6 major clinical study/ (352156) 7 double blind procedure/ (27710) 8 multicenter study/ (19950) 9 single blind procedure/ (3090) 10 crossover procedure/ (9288) 11 placebo/ (23129) 12 or/1-11 (1350338) 13 allocat$.ti,ab. (10381) 14 assign$.ti,ab. (34017) 15 blind$.ti,ab. (39706) 16 (clinic$ adj25 (study or trial)).ti,ab. (103723) 17 compar$.ti,ab. (592128) 18 control$.ti,ab. (435060) 19 cross?over.ti,ab. (7854) 20 factorial$.ti,ab. (2463) 21 follow?up.ti,ab. (3710) 22 placebo$.ti,ab. (32609) 23 prospectiv$.ti,ab. (81230) 24 random$.ti,ab. (119291) 25 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. (27455) 26 trial.ti,ab. (57298) 27 (versus or vs).ti,ab. (144304) 28 or/13-27 (1052880) 29 12 or 28 (1707121) 30 human/ (1767116) 31 nonhuman/ (855690) 32 animal/ (592) 33 animal experiment/ (266367) 34 31 or 32 or 33 (857723) 35 30 and 34 (145063) 36 29 not 34 (1118616) 37 29 and 35 (85582) 38 36 or 37 (1204198) 39 Lumbar Spine/ (4963) 40 Lumbosacral Spine/ (629) 41 Intervertebral Disk/ (710) 42 Intervertebral Disk Disease/ (295) 43 Lumbar Disk Hernia/ (835) 44 Low back pain/ (5403) 45 Ischialgia/ (743) 46 low back pain.tw. (3184) 47 backache.tw. (270) Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

9

48 lumbago.tw. (162) 49 or/39-48 (12240) 50 exp ACUPUNCTURE/ (2907) 51 exp ACUPUNCTURE ANALGESIA/ (143) 52 acupuncture.tw. (1775) 53 electro-acupuncture.tw. (56) 54 acupressure.tw. (71) 55 or/50-54 (3014) 56 38 and 49 and 55 (85) CINAHL S37 S36 S36 S29 and S35 S35 S30 or S31 or S32 or S33 or S34 S34 dry needling S33 acupressure S32 (MH ”Acupressure“) S31 acupuncture S30 (MH ”Acupuncture+“) S29 S12 and S28 S28 S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21 or S22 or S23 or S24 or S25 or S26 or S27 S27 lumbar W1 pain S26 ”lumbago“ S25 (MH ”Spondylolysis“) S24 (MH ”Spondylolisthesis“) S23 (MH ”Thoracic Vertebrae“) S22 (MH ”Lumbar Vertebrae“) S21 coccydynia S20 ”sciatica“ S19 ”coccyx“ S18 (MH ”Sciatica“) S17 (MH ”Coccyx“) S16 ”backache“ S15 (MH ”Low Back Pain“) S14 (MH ”Back Pain+“) S13 dorsalgia S12 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 S11 TX allocat* random* S10 (MH ”Quantitative Studies“) S9 (MH ”Placebos“) S8 TX placebo* S7 TX random* allocat* S6 (MH ”Random Assignment“) S5 TX randomi* control* trial* S4 TX ( (singl* n1 blind*) or (singl* n1 mask*) ) or TX ( (doubl* n1 blind*) or (doubl* n1 mask*) ) or TX ( (tripl* n1 blind*) or (tripl* n1 mask*) ) or TX ( (trebl* n1 blind*) or (trebl* n1 mask*) ) S3 TX clinic* n1 trial* S2 PT Clinical trial S1 (MH ”Clinical Trials+“) CENTRAL #1 MeSH descriptor Back explode all trees #2 MeSH descriptor Buttocks, this term only #3 MeSH descriptor Leg, this term only #4 MeSH descriptor Back Pain explode tree 1 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

10

#5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15 #16 #17 #18

MeSH descriptor Back Injuries explode all trees MeSH descriptor Low Back Pain, this term only MeSH descriptor Sciatica, this term only (low next back next pain) (lbp) (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9) MeSH descriptor Acupuncture explode all trees MeSH descriptor Acupuncture Therapy explode all trees MeSH descriptor Acupressure explode all trees acupuncture acupressure dry needling (#11 OR #12 OR #13 OR #14 OR #15 OR #16) (#10 AND #17)

Appendix 3. UO-EPC search strategies Ovid MEDLINE(R) 1950 to August Week 1 2009 1 exp Neck/ or exp spine/ or exp back/ or Neck Muscles/ or Zygapophyseal Joint/ 2 pain/ or pain, intractable/ or pain, referred/ 3 (pain* or ache*).tw. 4 3 or 2 5 4 and 1 6 exp back pain/ 7 exp back injuries/ 8 (backpain* or backache*).tw. 9 exp spinal injuries/ 10 exp spinal diseases/ 11 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 12 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 13 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 14 (Discitis or diskitis or Spondylodis*).tw. 15 (osteoporo* adj3 compression fracture*).tw. 16 vertebrogenic pain syndrome*.tw. 17 Sciatica/ 18 (Sciatica or ischialgia).tw. 19 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 20 Neck Pain/ 21 (cervicalgia or Cervicodynia).tw. 22 ((anterior or posterior) adj3 (cervical pain or cervical ache*)).tw. 23 ((cervicogenic or cervico-genic) adj3 headache*).tw. 24 exp neck injuries/ 25 (neckache* or neckpain*).tw. 26 (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*).tw. 27 (neck disorder* adj3 radicul*).tw. 28 (failed back or back surgery syndrome* or FBSS).tw. 29 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. 30 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. 31 (lumbago or dorsalgia).tw. 32 (myofascial adj3 (pain* or ache*)).tw. 33 or/5-32 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

11

34 Acupuncture/ 35 Acupuncture Therapy/ 36 Electroacupuncture/ 37 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric acupuncture or electric acu-puncture or needling or acupressure or acu-pressure or mox?bustion).tw. 38 exp Manipulation, Spinal/ 39 Manipulation, Chiropractic/ 40 Chiropractic/ 41 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 42 (Manual adj therap*).tw. 43 (Manipulati* adj (therap* or medicine)).tw. 44 exp Massage/ 45 (massag* or reflexolog* or rolfing or zone therap*).tw. 46 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya).tw. 47 (Flexion adj2 distraction*).tw. 48 (myofascial adj3 (release or therap*)).tw. 49 Muscle energy technique*.tw. 50 Trigger point*.tw. 51 Proprioceptive Neuromuscular Facilitation*.tw. 52 Cyriax Friction.tw. 53 (Lomilomi or lomi-lomi or trager).tw. 54 Aston patterning.tw. 55 (Strain adj counterstrain).tw. 56 Alexander technique*.tw. 57 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 58 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. 59 Complementary Therapies/ 60 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 61 (Tui Na or Tuina).tw. 62 or/34-61 63 33 and 62 The following filters were applied and overlap removed: Randomized/Controlled Clinical Trials 64 exp Randomized Controlled Trials as topic/ 65 Randomized Controlled Trial.pt. 66 Controlled Clinical Trial.pt. 67 (random* or sham or placebo*).tw. 68 Placebos/ 69 Random Allocation/ 70 Single Blind Method/ 71 Double Blind Method/ 72 ((singl* or doubl* or tripl* or trebl*) adj (blind* or dumm* or mask*)).tw. 73 (RCT or RCTs).tw. 74 (control* adj2 (study or studies or trial*)).tw. 75 or/64-74 76 63 and 75 77 animal/ 78 human/ 79 77 not (77 and 78) 80 76 not 79 Systematic Reviews 81 Meta-Analysis/ Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

12

82 exp Meta-Analysis as Topic/ 83 Meta analysis.pt. 84 (meta analy* or metaanaly* or met analy* or metanaly*).tw. 85 Review Literature as Topic/ 86 (collaborative research or collaborative review* or collaborative overview*).tw. 87 (integrative research or integrative review* or integrative overview*).tw. 88 (quantitative adj3 (research or review* or overview*)).tw. 89 (research integration or research overview*).tw. 90 (systematic* adj3 (review* or overview*)).tw. 91 (methodologic* adj3 (review* or overview*)).tw. 92 exp Technology Assessment, Biomedical/ 93 (hta or htas or technology assessment*).tw. 94 ((hand adj2 search*) or (manual* adj search*)).tw. 95 ((electronic adj database*) or (bibliographic* adj database*)).tw. 96 ((data adj2 abstract*) or (data adj2 extract*)).tw. 97 (Data adj3 (pool or pooled or pooling)).tw. (5850) 98 (Analys* adj3 (pool or pooled or pooling)).tw. 99 Mantel Haenszel.tw. 100 (Cochrane or PubMed or MEDLINE or EMBASE or PsycINFO or PsycLIT or PsychINFO or PsychLIT or CINAHL or Science Citation Index).ab. 101 or/81-100 102 63 and 101 103 102 not 79 104 103 not 80 Safety 81 (ae or to or po or co).fs. 82 (safe or safety or unsafe).tw. 83 (side effect* or side event*).tw. 84 ((adverse or undesirable or harm* or injurious or serious or toxic) adj3 (effect* or reaction* or event* or incident* or outcome*)).tw. 85 (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*).tw. 86 or/81-85 87 63 and 86 88 87 not 79 89 88 not 80 Economics 90 economics/ 91 exp ”costs and cost analysis“/ 92 Value of Life/ 93 economics medical/ 94 (econom* or cost or costs or costly or costing or price or prices or pricing).ti,ab. 95 (expenditure* not energy).ti,ab. 96 (value adj2 money).ti,ab. 97 budget.ti,ab. 98 or/90-97 99 63 and 98 100 99 not 79 101 100 not (80 or 89) EMBASE 1980 to 2009 Week 38 1 exp Neck/ or exp spine/ or exp back/ or Neck Muscle/ or Back Muscle/ or Zygapophyseal Joint/ 2 Pain/ or Intractable Pain/ or Referred Pain/ 3 (pain* or ache*).tw. 4 2 or 3 5 1 and 4 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

13

6 exp Backache/ 7 (backache or backpain).tw. 8 exp Spine Injury/ 9 exp Spine Disease/ 10 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 11 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 12 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 13 (Discitis or diskitis or Spondylodis*).tw. 14 (osteoporo* adj3 compression fracture*).tw. 15 vertebrogenic pain syndrome*.tw. 16 Ischialgia/ 17 (Ischialgia or sciatica).tw. 18 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 19 Neck Pain/ 20 (cervicalgia or Cervicodynia).tw. 21 ((anterior or posterior) adj3 (cervical pain or cervical ache*)).tw. 22 ((cervicogenic or cervico-genic) adj3 headache*).tw. 23 exp neck injuries/ 24 (neckache* or neckpain*).tw. 25 (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*).tw. 26 (failed back or back surgery syndrome* or FBSS).tw. 27 (myofascial adj3 (pain* or ache*)).tw. 28 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. 29 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. 30 (lumbago or dorsalgia).tw. 31 (neck disorder* adj3 radicul*).tw. 32 or/5-31 33 exp Acupuncture/ 34 Electroacupuncture/ 35 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric* acupuncture or electric* acu-puncture or needling or acupressure or acu-pressure or mox?bustion).tw. 36 exp Manipulative Medicine/ 37 chiropractic/ 38 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 39 (Manual adj therap*).tw. 40 (Manipulati* adj (therap* or medicine)).tw. 41 Massage/ 42 (massag* or reflexolog* or rolfing or zone therap*).tw. 43 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya).tw. 44 (Flexion adj2 distraction*).tw. 45 (myofascial adj3 (release or therap*)).tw. 46 Muscle energy technique*.tw. 47 Trigger point*.tw. 48 Proprioceptive Neuromuscular Facilitation*.tw. 49 Cyriax Friction.tw. 50 (Lomilomi or lomi-lomi or trager).tw. 51 Aston patterning.tw. 52 (Strain adj counterstrain).tw. 53 Alexander technique*.tw. 54 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 55 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

14

56 Alternative Medicine/ 57 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 58 (Tui Na or Tuina).tw. 59 or/33-58 60 32 and 59 The following filters were applied and overlap removed: Randomized/Controlled Clinical Trials 61 Randomized Controlled Trial/ 62 exp Controlled Clinical Trial/ 63 (random* or sham or placebo*).tw. 64 Placebo/ 65 Randomization/ 66 Single Blind Procedure/ 67 Double Blind Procedure/ 68 ((singl* or doubl* or tripl* or trebl*) adj (blind* or dumm* or mask*)).tw. 69 (RCT or RCTs).tw. 70 (control* adj2 (study or studies or trial*)).tw. 71 or/61-70 72 60 and 71 73 human.sh. 74 nonhuman.sh. 75 animal.sh. 76 animal experiment.sh. 77 or/74-76 78 77 not (73 and 77) 79 72 not 78 Systematic Reviews 80 Meta Analysis/ (34242) 81 ”systematic review“/ (24457) 82 (meta analy* or metaanaly* or met analy* or metanaly*).tw. (22067) 83 (collaborative research or collaborative review* or collaborative overview*).tw. (834) 84 (integrative research or integrative review* or integrative overview*).tw. (128) 85 (quantitative adj3 (research or review* or overview*)).tw. (1551) 86 (research integration or research overview*).tw. (59) 87 (systematic* adj3 (review* or overview*)).tw. (17008) 88 (methodologic* adj3 (review* or overview*)).tw. (1013) 89 biomedical technology assessment/ (5472) 90 (hta or htas or technology assessment*).tw. (1902) 91 ((hand adj2 search*) or (manual* adj search*)).tw. (2396) 92 ((electronic adj database*) or (bibliographic* adj database*)).tw. (2660) 93 ((data adj2 abstract*) or (data adj2 extract*)).tw. (11462) 94 (Data adj3 (pool or pooled or pooling)).tw. (4432) 95 (Analys* adj3 (pool or pooled or pooling)).tw. (3135) 96 Mantel Haenszel.tw. (1463) 97 (Cochrane or PubMed or MEDLINE or EMBASE or PsycINFO or PsycLIT or PsychINFO or PsychLIT or CINAHL or Science Citation Index).ab. (28709) 98 or/80-97 (100019) 99 60 and 98 (421) 100 99 not 78 (421) 101 100 not 79 (178) Safety 80 (ae or co or si or to).fs. 81 (safe or safety or unsafe).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

15

82 (side effect* or side event*).tw. 83 ((adverse or undesirable or harm* or injurious or serious or toxic) adj3 (effect* or reaction* or event* or incident* or outcome*)).tw. 84 (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*).tw. 85 or/80-84 86 60 and 85 87 86 not 78 88 87 not 79 Economics 89 health-economics/ 90 exp economic-evaluation/ 91 exp health-care-cost/ 92 (econom* or cost or costs or costly or costing or price or prices or pricing).ti,ab. 93 (expenditure* not energy).ti,ab. 94 (value adj2 money).ti,ab. 95 budget*.ti,ab. 96 socioeconomics/ 97 or/89-96 98 60 and 97 99 98 not 78 100 99 not (79 or 88) AMED 1 exp Neck/ or exp spine/ or exp back/ or Neck Muscles/ 2 pain/ or pain intractable/ 3 (pain* or ache*).tw. 4 2 or 3 5 1 and 4 6 exp backache/ 7 back injuries/ 8 (backache* or backpain*).tw. 9 spinal injuries/ 10 exp spinal disease/ 11 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 12 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 13 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 14 (Discitis or diskitis or Spondylodis*).tw. 15 (osteoporo* adj3 compression fracture*).tw. 16 vertebrogenic pain syndrome*.tw. 17 sciatica/ 18 (Sciatica or Ischialgia).tw. 19 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 20 neck pain/ 21 (cervicalgia or Cervicodynia).tw. 22 ((anterior or posterior) adj3 (cervical pain or cervical ache*)).tw. 23 ((cervicogenic or cervico-genic) adj3 headache*).tw. 24 exp neck injuries/ 25 (neckache* or neckpain*).tw. 26 (neck disorder* adj3 radicul*).tw. 27 (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*).tw. 28 (failed back or back surgery syndrome*).tw. 29 FBSS.tw. 30 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. 31 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

16

32 (lumbago or dorsalgia).tw. 33 (myofascial adj3 (pain* or ache*)).tw. 34 or/5-33 35 exp acupuncture/ 36 exp acupuncture therapy/ 37 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric acupuncture or electric acu-puncture or needling or acupressure or acu-pressure or mox?bustion).tw. 38 spinal manipulation/ 39 exp manipulation chiropractic/ 40 chiropractic/ 41 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 42 (Manual adj therap*).tw. 43 (Manipulati* adj (therap* or medicine)).tw. 44 massage/ 45 (massag* or reflexolog* or rolfing or zone therap*).tw. 46 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya).tw. 47 (Flexion adj2 distraction*).tw. 48 (myofascial adj3 (release or therap*)).tw. 49 Muscle energy technique*.tw. 50 Trigger point*.tw. 51 Proprioceptive Neuromuscular Facilitation*.tw. 52 Cyriax Friction.tw. 53 (Lomilomi or lomi-lomi or trager or Tui Na or Tuina).tw. 54 Aston patterning.tw. 55 (Strain adj counterstrain).tw. 56 Alexander technique*.tw. 57 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 58 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. 59 complementary therapies/ 60 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 61 or/35-60 62 34 and 61 The following filters were applied and overlap removed: Randomized/Controlled Clinical Trials 63 randomized controlled trials/ 64 randomized controlled trial.pt. 65 controlled clinical trial.pt. 66 (random* or sham or placebo*).tw. 67 Placebos/ 68 double blind method/ or random allocation/ 69 ((singl* or doubl* or tripl* or trebl*) adj (blind* or dumm* or mask*)).tw. 70 (RCT or RCTs).tw. 71 (control* adj2 (study or studies or trial*)).tw. 72 randomised controlled trial.pt. 73 or/63-72 74 62 and 73 Systematic Reviews 75 meta analysis/ 76 meta analysis.pt. 77 (meta analy* or metaanaly* or met analy* or metanaly*).tw. 78 (collaborative research or collaborative review* or collaborative overview*).tw 79 (integrative research or integrative review* or integrative overview*).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

17

80 (quantitative adj3 (research or review* or overview*)).tw. 81 (research integration or research overview*).tw. 82 (systematic* adj3 (review* or overview*)).tw. 83 (methodologic* adj3 (review* or overview*)).tw. 84 (hta or htas or technology assessment*).tw. 85 ((hand adj2 search*) or (manual* adj search*)).tw. 86 ((electronic adj database*) or (bibliographic* adj database*)).tw. 87 ((data adj2 abstract*) or (data adj2 extract*)).tw. 88 (Data adj3 (pool or pooled or pooling)).tw. 89 (Analys* adj3 (pool or pooled or pooling)).tw. 90 Mantel Haenszel.tw. 91 (Cochrane or PubMed or MEDLINE or EMBASE or PsycINFO or PsycLIT or PsychINFO or PsychLIT or CINAHL or Science Citation Index).ab. 92 or/75-91 (2843) 93 62 and 92 (150) 94 93 not 74 Safety 75 (safe or safety or unsafe).tw. 76 (side effect* or side event*).tw. 77 ((adverse or undesirable or harm* or injurious or serious or toxic) adj3 (effect* or reaction* or event* or incident* or outcome*)).tw 78 (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*).tw. 79 adverse effects/ 80 or/75-79 81 62 and 80 82 81 not 74 Economics 84 Economics/ 85 exp ”costs and cost analysis“/ or patient satisfaction/ or ”quality of life“/ 86 (econom* or cost or costs or costly or costing or price or prices or pricing or budget*).ti,ab. 87 (expenditure* not energy).ti,ab. 88 (value adj2 money).ti,ab. 89 (QOL or QOLY or QOLYs or HRQOL or QALY or QALYs).ti,ab. 90 or/84-89 91 62 and 90 92 91 not (74 or 82) ACP Journal Club 1 (backpain* or backache*).tw. 2 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 3 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 4 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 5 (Discitis or diskitis or Spondylodis*).tw. 6 (osteoporo* adj3 compression fracture*).tw. 7 vertebrogenic pain syndrome*.tw. 8 (Sciatica or ischialgia).tw. 9 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 10 (cervicalgia or Cervicodynia).tw. 11 ((anterior or posterior) adj3 (cervical pain or cervical ache*)).tw. 12 ((cervicogenic or cervico-genic) adj3 headache*).tw. 13 (neckache* or neckpain*).tw. 14 (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*).tw. 15 (failed back or back surgery syndrome* or FBSS).tw. 16 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

18

17 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. 18 (lumbago or dorsalgia).tw. 19 (myofascial adj3 (pain* or ache*)).tw. 20 (neck disorder* adj3 radicul*).tw. 21 or/1-20 22 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric acupuncture or electric acu-puncture or needling or acupressure or acu-pressure or mox?bustion).tw. 23 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 24 (Manual adj therap*).tw. 25 (Manipulati* adj (therap* or medicine)).tw. 26 (massag* or reflexolog* or rolfing or zone therap*).tw. 27 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya).tw. 28 (Flexion adj2 distraction*).tw. 29 (myofascial adj3 (release or therap*)).tw. 30 Muscle energy technique*.tw. 31 Trigger point*.tw. 32 Proprioceptive Neuromuscular Facilitation*.tw. 33 Cyriax Friction.tw. 34 (Lomilomi or lomi-lomi or trager or Tui Na or Tuina).tw. 35 Aston patterning.tw. 36 (Strain adj counterstrain).tw. 37 Alexander technique*.tw. 38 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 39 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. 40 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 41 or/22-40 42 21 and 41 CINAHL 1 Neck/ 2 Back/ 3 exp Spine/ 4 Neck Muscles/ 5 or/1-4 6 pain/ 7 Referred Pain/ 8 (pain* or ache*).tw. 9 or/6-8 10 5 and 9 11 exp Back Pain/ 12 exp Back Injuries/ 13 (backache* or backpain*).tw. 14 exp Spinal Injuries/ 15 exp Spinal Diseases/ 16 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 17 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 18 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 19 (Discitis or diskitis or Spondylodis*).tw. 20 (osteoporo* adj3 compression fracture*).tw. 21 vertebrogenic pain syndrome*.tw. 22 Sciatica/ 23 (Sciatica or Ischialgia).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

19

24 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 25 Neck Pain/ 26 (cervicalgia or Cervicodynia).tw. 27 ((anterior or posterior) adj3 (cervical pain* or cervical ache*)).tw. 28 ((cervicogenic or cervico-genic) adj3 headache*).tw. 29 exp Neck Injuries/ 30 (neckache* or neckpain*).tw. 31 (whiplash* or whip lash*).tw. 32 (failed back or back surgery syndrome* or FBSS).tw. 33 (neck disorder* adj3 radicul*).tw. 34 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. 35 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. 36 (lumbago or dorsalgia).tw. 37 (myofascial adj3 (pain* or ache*)).tw. 38 or/10-37 39 exp Acupuncture/ 40 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric* acupuncture or electric* acu-puncture or acupressure or acu-pressure or mox?bustion).tw. 41 exp chiropractic/ or manipulation, chiropractic/ 42 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 43 (Manual adj therap*).tw. 44 (Manipulati* adj (therap* or medicine)).tw. 45 exp Massage/ 46 (massag* or reflexolog* or rolfing or zone therap*).tw. 47 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya or Tui Na).tw. 48 (Flexion adj2 distraction*).tw. 49 (myofascial adj3 (release or therap*)).tw. 50 Muscle energy technique*.tw. 51 Trigger point*.tw. 52 Proprioceptive Neuromuscular Facilitation*.tw. 53 Cyriax Friction.tw. 54 (Lomilomi or lomi-lomi or trager or Tui Na or Tuina).tw. 55 Aston patterning.tw. 56 (Strain adj counterstrain).tw. 57 Alexander technique*.tw. 58 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 59 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. 60 Alternative Therapies/ 61 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 62 or/39-61 63 38 and 62 The following filters were applied and overlap removed: Randomized/Controlled Clinical Trials 64 exp Clinical Trials/ 65 clinical trial.pt. 66 (random* or sham or placebo*).tw. 67 Placebos/ 68 Random Assignment/ 69 ((singl* or doubl* or tripl* or trebl*) adj (blind* or dumm* or mask*)).tw. 70 (RCT or RCTs).tw. 71 (control* adj2 (study or studies or trial*)).tw. 72 or/64-71 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

20

73 63 and 72 Systematic Reviews 74 systematic review.pt. 75 Meta Analysis/ 76 (meta analy* or metaanaly* or met analy* or metanaly*).tw. 77 (collaborative research or collaborative review* or collaborative overview*).tw. 78 (integrative research or integrative review* or integrative overview*).tw. 79 (quantitative adj3 (research or review* or overview*)).tw. 80 (integrative research or research integration or research overview*).tw. 81 (systematic* adj3 (review* or overview*)).tw. 82 (methodologic* adj3 (review* or overview*)).tw. 83 (hta or htas or technology assessment*).tw. 84 ((hand adj2 search*) or (manual* adj2 search*)).tw. 85 ((electronic adj database*) or (bibliographic* adj database*)).tw. 86 ((data adj2 abstract*) or (data adj2 extract*)).tw. 87 (data adj3 (pool or pooled or pooling)).tw. 88 (analys* adj3 (pool or pooled or pooling)).tw. 89 Mantel Haenszel.tw. 90 (Cochrane or PubMed or MEDLINE or EMBASE or PsycINFO or PsycLIT or PsychINFO or PsychLIT or CINAHL or Science Citation Index).ab. 91 or/74-90 92 63 and 91 93 92 not 73 Safety 74 (safe or safety or unsafe).tw. 75 (side effect* or side event*).tw. 76 ((adverse or undesirable or harm* or injurious or serious or toxic) adj3 (effect* or reaction* or event* or incident* or outcome*)).tw. 77 (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*).tw. 78 (ae or po or co).fs. 79 or/74-78 80 63 and 79 81 80 not 73 Economics 84 exp economics/ (258163) 85 exp financial management/ (17991) 86 exp financial support/ (168377) 87 exp ”financing organized“/ (51967) 88 exp ”business“/ (26100) 89 or/85-88 (249186) 90 84 not 89 (24912) 91 health resource allocation/ (3423) 92 health resource utilization/ (4982) 93 exp ”Quality of Life“/ (23733) 94 Patient Satisfaction/ (14059) 95 (econom* or cost or costs or costly or costing or price or prices or pricing or budget*).ti,ab. (53804) 96 (expenditure* not energy).ti,ab. (2243) 97 (value adj2 money).ti,ab. (187) 98 (QOL or QOLY or QOLYs or HRQOL or QALY or QALYs).ti,ab. (3012) 99 or/90-98 (107583) 100 63 and 99 (255) 101 100 not (73 or 81) MANTIS 1 neck.de. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

21

2 (spine or Cervical Vertebrae or Coccyx or Intervertebral Disk or Lumbar Vertebrae or Sacrum or Spinal Canal or Thoracic Vertebrae).de. 3 (Back or Lumbosacral Region or Sacrococcygeal Region).de. 4 neck muscles.de. 5 Zygapophyseal Joint.de. 6 or/1-5 7 pain.de. 8 pain, intractable.de. 9 pain, referred.de. 10 (pain* or ache* or aching).tw. 11 or/7-10 12 6 and 11 13 (back pain or low back pain).de. 14 back injuries.de. 15 (backpain* or backache*).tw. 16 (spinal injuries or spinal fractures).de. 17 (spinal diseases or Intervertebral Disk Displacement or Spinal Stenosis or Spondylolisthesis or Spondylolysis).de. 18 ((disc* or disk*) adj3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped)).tw. 19 ((stenosis or stenoses) adj3 (lumbar or spine or spines or spinal)).tw. 20 (Spondylolys* or spondylolisthes* or Spondylisthes*).tw. 21 (Discitis or diskitis or Spondylodis*).tw. 22 (osteoporo* adj3 compression fracture*).tw. 23 vertebrogenic pain syndrome*.tw. 24 Sciatica.de. 25 (Sciatica or ischialgia).tw. 26 (Sciatic adj3 (Neuralgia or Bilateral)).tw. 27 neck pain.de. 28 (cervicalgia or Cervicodynia).tw. 29 ((anterior or posterior) adj3 (cervical pain or cervical ache*)).tw. 30 ((cervicogenic or cervico-genic) adj3 headache*).tw. 31 (neck injuries or Whiplash Injuries).de. 32 (neckache* or neckpain*).tw. 33 (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*).tw. 34 (neck disorder* adj3 radicul*).tw. 35 failed back surgery.de. 36 (failed back or back surgery syndrome* or FBSS).tw. 37 facet syndrome.de. 38 ((Zygapophyseal or Facet or facets) adj3 (syndrome* or degenerat*)).tw. 39 ((back or neck or spine or spinal or lumbar* or thoracic) adj3 (ache* or aching or pain* or strain*)).tw. 40 (lumbago or dorsalgia).tw. 41 (myofascial pain syndromes or myofascial).de. 42 (myofascial adj3 (pain* or ache*)).tw. 43 or/12-42 44 Acupuncture.de. 45 Acupuncture Therapy.de. 46 electroacupuncture.de. 47 (Acupuncture or acu-puncture or electroacupuncture or electro-acupuncture or electric acupuncture or electric acu-puncture or needling or acupressure or acu-pressure or mox?bustion).tw. 48 Manipulation, Spinal.de. 49 Manipulation, Chiropractic.de. 50 Chiropractic.de. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

22

51 ((back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) adj3 (adjust* or manipulat* or mobiliz* or mobilis*)).tw. 52 (Manual adj therap*).tw. 53 (Manipulati* adj (therap* or medicine)).tw. 54 (Massage or Acupressure).de. 55 (massag* or reflexolog* or rolfing or zone therap*).tw. 56 (Chih Ya or Shiatsu or Shiatzu or Zhi Ya).tw. 57 (Flexion adj2 distraction*).tw. 58 (myofascial adj3 (release or therap*)).tw. 59 Muscle energy technique*.tw. 60 Trigger point*.tw. 61 Proprioceptive Neuromuscular Facilitation*.tw. 62 Cyriax Friction.tw. 63 (Lomilomi or lomi-lomi or trager).tw. 64 Aston patterning.tw. 65 (Strain adj counterstrain).tw. 66 Alexander technique*.tw. 67 (Craniosacral Therap* or Cranio-sacral Therap*).tw. 68 (amma or ammo or Effleurage or Petrissage or hacking or Tapotment).tw. 69 Complementary Therapies.de. 70 ((complement* or alternat* or osteopathic*) adj (therap* or medicine)).tw. 71 (Tui Na or Tuina).tw. 72 or/44-71 73 43 and 72 The following filters were applied and overlap removed: Randomized/Controlled Clinical Trials 74 (Randomized Controlled Trial or Randomized Controlled Trials).de. 75 (Controlled Clinical Trial or Controlled Clinical Trials).de. 76 (random* or sham or placebo*).tw. 77 Placebos.de. 78 Random Allocation.de. 79 Single Blind Method.de. 80 Double Blind Method.de. 81 ((singl* or doubl* or tripl* or trebl*) adj (blind* or dumm* or mask*)).tw. 82 (RCT or RCTs).tw. 83 (control* adj2 (study or studies or trial*)).tw. 84 or/74-83 85 animal.de. 86 human.de. 87 85 not (85 and 86) 88 73 and 84 89 88 not 87 Systematic Reviews 90 Meta-Analysis.de. 91 (meta analy* or metaanaly* or met analy* or metanaly*).tw. 92 (collaborative research or collaborative review* or collaborative overview*).tw. 93 (integrative research or integrative review* or integrative overview*).tw. 94 (quantitative adj3 (research or review* or overview*)).tw. 95 (research integration or research overview*).tw. 96 (systematic* adj3 (review* or overview*)).tw. 97 (methodologic* adj3 (review* or overview*)).tw. 98 Technology Assessment, Biomedical.de. 99 (hta or htas or technology assessment*).tw. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

23

100 ((hand adj2 search*) or (manual* adj search*)).tw. 101 ((electronic adj database*) or (bibliographic* adj database*)).tw. 102 ((data adj2 abstract*) or (data adj2 extract*)).tw. 103 (Data adj3 (pool or pooled or pooling)).tw. 104 (Analys* adj3 (pool or pooled or pooling)).tw. 105 Mantel Haenszel.tw. 106 (Cochrane or PubMed or MEDLINE or EMBASE or PsycINFO or PsycLIT or PsychINFO or PsychLIT or CINAHL or Science Citation Index).ab. 107 or/90-106 108 73 and 107 109 108 not 87 110 109 not 89 Safety 90 (safe or safety or unsafe).tw. 91 (side effect* or side event*).tw. 92 ((adverse or undesirable or harm* or injurious or serious or toxic) adj3 (effect* or reaction* or event* or incident* or outcome*)).tw. 93 (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*).tw. 94 adverse effects.de. 95 complications.de. 96 toxicity.de. 97 or/90-96 98 73 and 97 99 98 not 87 100 99 not 89 Economics 101 economics.de. 102 ”costs and cost analysis“.de. 103 ”value of life“.de. 104 economics, medical.de. 105 (econom* or cost or costs or costly or costing or price or prices or pricing).ti,ab. 106 (expenditure* not energy).ti,ab. 107 (value adj2 money).ti,ab. 108 budget.ti,ab. 109 cost benefit analysis.de. 110 or/101-109 111 73 and 110 112 111 not 87 113 112 not (89 or 100) Cochrane Library 2009 Issue 2 Systematic Review and RCT/CCT 1 MeSH descriptor Neck explode all trees 2 MeSH descriptor Spine explode all trees 3 MeSH descriptor Back explode all trees 4 MeSH descriptor Neck Muscles explode all trees 5 MeSH descriptor Zygapophyseal Joint explode all trees 6 MeSH descriptor Pain explode all trees 7 MeSH descriptor Pain, Intractable explode all trees 8 MeSH descriptor Pain, Referred explode all trees 9 (pain* or ache*):ti,ab,kw 10 (1 OR 2 OR 3 OR 4 OR 5) 11 (6 OR 7 OR 8 OR 9) 12 (10 AND 11) 13 MeSH descriptor Back Pain explode all trees Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

24

14 MeSH descriptor Back Injuries explode all trees 15 (backpain* or backache*):ti,ab,kw 16 MeSH descriptor Spinal Injuries explode all trees 17 MeSH descriptor Spinal Diseases explode all trees 18 (disc* or disk*) NEAR/3 (degener* or displace* or prolapse* or hernia* or bulge or protrusion* or extrusion* or sequestration* or disorder* or disease* or rupture* or slipped):ti,ab,kw 19 (stenosis or stenoses) NEAR/3 (lumbar or spine or spines or spinal):ti,ab,kw 20 (Spondylolys* or spondylolisthes* or Spondylisthes*):ti,ab,kw or (Discitis or diskitis or Spondylodis*):ti,ab,kw 21 (osteoporo* NEAR/3 compression fracture*):ti,ab,kw 22 (vertebrogenic pain syndrome*):ti,ab,kw 23 MeSH descriptor Sciatica explode all trees 24 (Sciatica or ischialgia):ti,ab,kw or (Sciatic NEAR/3 (Neuralgia or Bilateral)):ti,ab,kw 25 MeSH descriptor Neck Pain explode all trees 26 (cervicalgia or Cervicodynia):ti,ab,kw or (anterior or posterior) NEAR/3 (cervical pain or cervical ache*):ti,ab,kw or (cervicogenic or cervico-genic) NEAR/3 headache*:ti,ab,kw 27 MeSH descriptor Neck Injuries explode all trees 28 (neckache* or neckpain*):ti,ab,kw or (whiplash* or whip lash* or radiculomyelopath* or radiculo-myelopath*):ti,ab,kw or (failed back or back surgery syndrome* OR FBSS):ti,ab,kw or (lumbago or dorsalgia):ti,ab,kw 29 (neck disorder*) NEAR/3 radicul*:ti,ab,kw or (Zygapophyseal or Facet or facets) NEAR/3 (syndrome* or degenerat*):ti,ab,kw or (back or neck or spine or spinal or lumbar* or thoracic) NEAR/3 (ache* or aching or pain* or strain*):ti,ab,kw or (myofascial adj3 (pain* or ache*)):ti,ab,kw 30 (12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22 OR 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29) 31 MeSH descriptor Acupuncture explode all trees 32 MeSH descriptor Acupuncture Therapy explode all trees 33 MeSH descriptor Electroacupuncture explode all trees 34 (acupuncture or electric acupuncture or electric acu-puncture or needling or acupressure or acu-pressure or mox?bustion):ti,ab,kw 35 MeSH descriptor Manipulation, Spinal explode all trees 36 MeSH descriptor Manipulation, Chiropractic explode all trees 37 MeSH descriptor Chiropractic explode all trees 38 (back or neck or spine or spinal or lumbar or cervical or chiropractic* or musculoskeletal* or musculo-skeletal*) NEAR/3 (adjust* or manipulat* or mobiliz* or mobilis*):ti,ab,kw or (Manual NEXT therap*):ti,ab,kw or (Manipulati* NEXT (therap* or medicine)):ti,ab,kw 39 MeSH descriptor Massage explode all trees 40 (massag* or reflexolog* or rolfing or zone therap*):ti,ab,kw or (Chih Ya or Shiatsu or Shiatzu or Zhi Ya):ti,ab,kw or (Flexion NEAR/2 distraction*):ti,ab,kw or (myofascial NEAR/3 (release or therap*)):ti,ab,kw or (Muscle energy technique*):ti,ab,kw 41 (Trigger point*):ti,ab,kw or (Proprioceptive Neuromuscular Facilitation*):ti,ab,kw or (Cyriax Friction):ti,ab,kw or (Lomilomi or lomi-lomi or trager or Tui Na or Tuina):ti,ab,kw or (Aston patterning):ti,ab,kw 42 (Strain NEAR/1 counterstrain):ti,ab,kw or (Alexander technique*):ti,ab,kw or (Craniosacral Therap* or Cranio-sacral Therap*): ti,ab,kw or (amma or ammo or Effleurage or Petrissage or hacking or Tapotment):ti,ab,kw or (complement* or alternat* or osteopathic*) NEXT (therap* or medicine):ti,ab,kw 43 MeSH descriptor Complementary Therapies, this term only 44 (31 OR 32 OR 33 OR 34 OR 35 OR 36 OR 37 OR 38 OR 39 OR 40 OR 41 OR 42 OR 43) 45 (30 AND 44) Safety 46 Any MeSH descriptor with qualifier: AE 47 Any MeSH descriptor with qualifier: TO 48 Any MeSH descriptor with qualifier: PO 49 Any MeSH descriptor with qualifier: CO 50 (safe or safety or unsafe):ti,ab,kw or (side effect* or side event*):ti,ab,kw or (adverse or undesirable or harm* or injurious or serious or toxic) NEAR/3 (effect* or reaction* or event* or incident* or outcome*):ti,ab,kw or (abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit*):ti,ab,kw 51 (46 OR 47 OR 48 OR 49 OR 50) Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

25

52 (45 AND 51) Economics 53 MeSH descriptor Economics, this term only 54 MeSH descriptor Economics, Medical, this term only 55 MeSH descriptor Costs and Cost Analysis explode all trees 56 MeSH descriptor Value of Life explode all trees 57 MeSH descriptor Quality-Adjusted Life Years explode all trees 58 MeSH descriptor Patient Satisfaction explode all trees 59 Any MeSH descriptor with qualifier: EC 60 (econom* or cost or costs or costly or costing or price or prices or pricing or budget*):ti,ab,kw or (expenditure* not energy): ti,ab,kw or (value NEAR/2 money):ti,ab,kw or (QOL or QOLY or QOLYs or HRQOL or QALY or QALYs):ti,ab,kw 61 (53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60) 62 (45 AND 61) 63 (62 AND NOT 52) Index to Chiropractic Literature 2008 Oct 10 S1 Subject:: ”BACK PAIN“ OR ”BACK INJURIES“ OR ”NECK INJURIES“ OR ”NECK PAIN“ OR ”SPINAL DISEASES“ OR ”SPINAL INJURIES“ OR ”SCIATICA“ OR All Fields:backpain* or backache* OR ”back pain“ OR ”back ache“ OR ”back pains“ OR ”back aches“ OR neckpain* OR neckache* OR ”neck pain“ OR neck ache” OR “neck pains” OR “neck aches” OR All Fields: Spondylolys* or spondylolisthes* or Spondylisthes* or Discitis or diskitis or Spondylod* OR Sciatica OR ischialgia* OR cervicalgia OR Cervicodynia S2 All Fields:whiplash* or “whip lash” OR “whip lashes” or radiculomyelopath* or “radiculo-myelopathy” OR “radiculomyelopathies” OR All Fields:“failed back” or “back surgery syndrome” or “back surgery syndromes” or FBSS OR All Fields:lumbago or dorsalgia or “myofascial pain” OR “myofascial ache” S3 All Fields:“cervical pain” OR “cervical ache” OR “vertebrogenic pain syndrome” OR “vertebrogenic pain syndromes” OR All Fields:“degenerated disk” OR “degenerative disk” OR “degenerated disks” OR “degenerative disks” OR All Fields:“degenerated disc” OR “degenerative disc OR ”degenerated discs“ OR ”degenerative discs“ S4 All Fields:”prolapsed disk“ OR ”prolapsed disks“ OR ”prolapsed disc“ OR ”prolapsed discs“ OR ”disk prolapse“ OR ”disc prolapse“ ”herniated disk“ OR ”herniated disks“ OR ”herniated disc“ OR ”herniated discs“ OR All Fields:”displaced disk“ OR ”displaced disks“ OR ”displaced disc“ OR ”displaced discs“ OR ”osteoporotic compression fracture“ OR ”osteoporotic compression fractures“ OR All Fields::”lumbar stenosis“ OR ”lumbar stenoses“ OR ”spinal stenosis“ OR ”spinal stenoses“ OR ”cervicogenic headache“ OR ”cervicogenic headaches“ OR ”cervico-genic headache“ OR ”cervico-genic headaches“ S5 All Fields:radiculomyelopathy OR radiculomyelopathies OR ”radiculo-myelopathy“ OR ”radiculo-myelopathies“ OR All Fields:”Zygapophyseal joint syndrome“ OR ”Zygapophyseal joint syndromes“ OR ”Z-joint syndrome“ OR ”Z-joint syndromes“ OR ”facet joint syndrome“ OR ”facet joint syndromes“ OR All Fields:”thoracic pain“ OR ”thoracic ache“ OR ”spinal pain“ OR ”spinal ache“ OR ”lumbar pain“ OR ”lumbar ache“ S6 S1 OR S2 OR S3 OR S4 OR S5 S7 Subject:”ACUPUNCTURE“ OR ”ACUPRESSURE“ OR ”ACUPUNCTURE THERAPY“ OR ”ELECTROACUPUNCTURE“ OR ”MANIPULATION, LUMBAR“ OR ”MANIPULATION, CERVICAL“ OR ”MANIPULATION, CHIROPRACTIC“ OR ”MANIPULATION, SPINAL“ OR ”MANIPULATION, THORACIC“ OR Subject:”MASSAGE“ OR ”CHIROPRACTIC“ OR All Fields:acupuncture or ”acu-puncture“ or electroacupuncture or ”electro-acupuncture“ or ”electric acupuncture“ or ”electric acu-puncture“ or needling or acupressure or ”acu-pressure“ or moxibustion or moxabustion S8 All Fields:”manual therapy“ OR ”manual therapies“ OR massag* or reflexolog* or rolfing or ”zone therapy“ or ”zone therapies“ OR All Fields:”Chih Ya“ or Shiatsu or Shiatzu or ”Zhi Ya“ or ”Flexion distraction“ OR ”Trigger point“ OR ”Trigger points“ OR ”Proprioceptive Neuromuscular Facilitation“ OR ”Proprioceptive Neuromuscular Facilitations“ OR All Fields:”myofascial release“ or ”myofascial therapy“ OR ”myofascial therapies“ OR ”Muscle energy technique“ OR ”Muscle energy techniques“ OR ”Cyriax Friction“ S9 All Fields:: Lomilomi or ”lomi-lomi“ or trager or ”Aston patterning“ or ”Strain counterstrain“ or ”Alexander technique“ or ”Alexander techniques“ or ”Tui Na“ or Tuina OR All Fields:Craniosacral Therapy” or “Craniosacral Therapies” or “Cranio-sacral Therapy”or “Cranio-sacral Therapies” or amma or ammo or Effleurage or Petrissage or hacking or Tapotment OR All Fields:manipulat* or mobiliz* or mobilis* S10 All Fields:“complementary therapy” OR “complementary therapies” OR “complementary medicine” OR All Fields:“alternative therapy” OR “alternative therapies” OR “alternative medicine” OR All Fields:“osteopathic therapy” OR “osteopathic therapies” OR “osteopathic medicine” Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

26

S11 S7 OR S8 OR S9 OR S10 S12 S6 AND S11 Randomized/Controlled Clinical Trials S13 Publication Type:Randomized Controlled Trial S14 Subject:“RANDOMIZED CONTROLLED TRIALS AS TOPIC” OR “CONTROLLED CLINICAL TRIALS” OR “PLACEBOS” OR All Fields:random* or sham or placebo* or RCT or RCTs or CCT or CCTs OR All Fields:“controlled clinical trial” or “controlled clinical trials” or “controlled study” or “controlled studies” or “control study” or “controlled studies” S15 S12 AND S14 S16 S13 OR S15 Safety S17 All Fields:safe or safety or unsafe or “side effect” or “side effects” or “side event” or “side events” OR All Fields:abnormalit* or toxicit* or complication* or consequence* or noxious or tolerabilit* OR All Fields:adverse or undesirable or harm* or injurious or serious or toxic S18 S12 AND S17 Economics S19 Subject:“ECONOMICS” OR “ECONOMICS, MEDICAL” OR “COSTS AND COST ANALYSIS” OR All Fields:econom* or cost or costs or costly or costing or price or prices or pricing or budget* or expenditure or value or money S20 S12 AND S19 LILACS 2008 Oct 13 ( ( ( ( ( “BACK PAIN” or “NECK PAIN” ) or “SPINAL DISEASES” ) or “BACK INJURIES” ) or “SPINAL INJURIES” ) or “NECK INJURIES” ) or “SCIATICA” [Descritor de assunto] and acupuncture or electroacupuncture or acupressure or massage or manipulation or chiropractic or osteopathic [Palavras] Acubriefs 2008 Oct 10 KW: Back pain + SPECIALTY: RCT/randomized controlled trials KW: neck pain + SPECIALTY: RCT/randomized controlled trials KW: thoracic pain + SPECIALTY: RCT/randomized controlled trials KW: spinal diseases + SPECIALTY: RCT/randomized controlled trials KW: lumbago + SPECIALTY: RCT/randomized controlled trials KW: facet joint + SPECIALTY: RCT/randomized controlled trials Excluded PubMed refs, ACP Jnl Club, Cochrane, ClinicalTrials.gov, animal studies

Appendix 4. Grey literature searches Grey Literature Searches HTAs, Systematic Reviews. 1 Epidemiology. 4 Guidelines. 4 Canadian. 4 U.S. 4 International 7 Clinical Trials. 8 Not yet recruiting. 8 Recruiting. 8 Ongoing. 10 Completed. 10 Econ. 14 Safety. 14 Critical Appraisals. 14 Misc. 15 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

27

HTAs, Systematic Reviews

28 items The efficacy of acupuncture to treat lumbar pain and acute pain, in a variety of situations. Andalusian Agency for Health Technology Assessment (AETSA). 2007 http://www.juntadeandalucia.es/salud/orgdep/aetsa/descarga.asp?id=100; http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp? ID=32008100058 Mapping the evidence base and use of acupuncture within the NHS. WMHTAC (Univ of Birmingham), 2006. http:// www.rep.bham.ac.uk/2006/Mapping_Acupunture.pdf Methods of treating chronic pain: a systematic review. SBU, 2006. http://www.sbu.se/en/Published/Yellow/Methods-of-TreatingChronic-Pain/ Chronic Low Back Pain. Belgian Health Care Knowledge Centre, 2006. http://www.kce.fgov.be/Download.aspx?ID=712 Costs and Outcomes of Chiropractic Treatment for Low Back Pain. CADTH, 2005. http://www.cadth.ca/media/pdf/ 225_chiro_tr_e.pdf Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain. HTA 2005, Vol 9, no 32. http://www.ncchta.org/fullmono/mon932.pdf Effectiveness of manual therapy in the treatment of non-specific neck pain: a review. Physical Therapy Reviews 2005;10(1):35-50 http://www.ingentaconnect.com/content/maney/ptr/2005/00000010/00000001/art00005 (May have been picked up in database search - check RM/SRS) Decompression therapy for the treatment of lumbosacral pain. AHRQ, 2004. http://www.cms.hhs.gov/determinationprocess/ downloads/id47TA.pdf Avis d’évaluation | Accès direct aux soins de chiropratique pour les accidentés de la route ayant été victimes d’un coup de fouet cervical antéro-postérieur ( whiplash »). AETMIS, 2003. http://www.aetmis.gouv.qc.ca/site/download.php? f=07a0517982a5be662f618eaf59d841e0 Spinal Manipulation for chronic neck pain. STEER, 2003. http://www.wihrd.soton.ac.uk/projx/signpost/steers/STEER_2004(4).pdf Spinal Manipulation for chronic low back pain. STEER, 2003. http://www.wihrd.soton.ac.uk/projx/signpost/steers/ STEER_2004(2).pdf Multidisciplinary care for chronic low back pain (Citation only). Centre for Clinical Effectiveness, Oct 2003 State of the art on double-electrode medullary electrostimulation. CAHTA, 2003. http://www.gencat.net/salut/depsan/units/aatrm/ pdf/in0302es.pdf Outpatient physiotherapy services for low back pain. STEER, 2002. http://www.wihrd.soton.ac.uk/projx/signpost/steers/ STEER_2002(3).pdf Spinal Manipulation for Lower Back Pain (Preassessment). CCOHTA, 2002. http://www.cadth.ca/media/pdf/ 225_No13_spinalmanipulation_preassess_e.pdf Trigger Point Injections for Chronic Non-malignant Musculoskeletal Pain. AHFMR, 2002. http://www.ihe.ca/documents/ HTA35.FINAL.pdf Trigger Point Injections for Non-Malignant Chronic Pain. AHFMR, 2002. http://www.ihe.ca/documents/tn39.pdf A Selected Inventory of Abstracts for Systematic Reviews on Chiropractic Services. AHFMR, 2002. http://www.ihe.ca/documents/ expert_advisory_committee_chiropractic.pdf Acupuncture: Evidence from Systematic Reviews and Meta-analyses. AHFMR, 2002. http://www.ihe.ca/documents/acupuncture.pdf Effectiveness of acupuncture for the treatment and rehabilitation of accident-related musculoskeletal disorders. A systematic review of the literature. NZHTA, 2002. http://nzhta.chmeds.ac.nz/publications/acupuncture.pdf Spinal cord stimulation for chronic pain. STEER, 2001. http://www.wihrd.soton.ac.uk/projx/signpost/steers/STEER_2001(5).pdf Back and neck pain. SBU, 2000. http://www.sbu.se/en/Published/Yellow/Back-and-neck-pain/ Evidence-based physiotherapy for patients with low back pain. SBU, 1999. http://www.sbu.se/en/Published/Vit/1929/ Evidence-based physiotherapy for patients with neck pain. SBU, 1999. http://www.sbu.se/en/Published/Vit/1928/ Low back pain: frequency, management and prevention from an HTA perspective. DACEHTA, 1999. http://www.sst.dk/Applikationer/ cemtv/publikationer/docs/Low-back%20pain/LowBackPain.pdf Management of the lumbosacral radicular syndrome (sciatica). Health Council of the Netherlands, 1999. http://www.gr.nl/ samenvatting.php?ID=469&highlight=back Standard care only Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

28

Chiropractic Treatment of Neck and Back Disorders: A Review of Selected Studies. CCOHTA, 1992. http://www.cadth.ca/index.php/ en/hta/reports-publications/search/publication/88 Back pain - causes, diagnosis, treatment. SBU, 1991. http://www.sbu.se/en/Published/Yellow/1865/

Epidemiology 2 items Prevalence of chronic pain: an overview. AHFMR, 2002. http://www.ihe.ca/documents/prevalence_chronic_pain.pdf Cole D, Ibrahim S, Shannon H, Scott F, Eyles. J. Work correlates of back problems and activity restriction due to musculoskeletal disorders in the Canadian national population health survey. Occupational and Environmental Medicine 2001;58:728-34. http:// oem.bmj.com/cgi/content/abstract/58/11/728

Guidelines

Canadian 3 items Acute Low Back Pain. Guidelines Advisory Committee, 2007. http://gacguidelines.ca/index.cfm?ACT=topics&Summary_ID=212& Topic_ID=17 Derived from: Australian Acute Musculoskeletal Pain Group. (2003). Evidence-based management of acute musculoskeletal pain. Acute low back pain: Chapter 4, pages 25-62. Process report: Chapter 9, pages 183-188. Evidence-Based Treatment of Adult Neck Pain Not Due to Whiplash. Canadian Chiropractic Association, 2005. http:// www.ccachiro.org/Client/cca/cca.nsf/web/CPG-sep-05?OpenDocument Gross AR, Kay TM, Kennedy C, et al Clinical practice guidelines on the use of manipulation or mobilization in the treatment of adults with mechanical neck disorders. Manual Therapy 2002;7(4):193-205 Abstract: http://www.ncbi.nlm.nih.gov/pubmed/12419654

U.S. 20 items Assessment and management of Chronic Pain, 3rd ed. ICSI, 2008. http://www.icsi.org/guidelines_and_more/gl_os_prot/musculoskeletal/pain__chronic__assessment_and_management_of_14399/ pain__chronic__assessment_and_management_of_14400.html Assessment and management of Acute Pain, 6th ed. ICSI, 2008 http://www.icsi.org/guidelines_and_more/gl_os_prot/musculo-skeletal/pain_acute/ pain__acute__assessment_and_management_of__2.html http://www.guideline.gov/summary/summary.aspx?doc_id=12540&nbr=006456&string= Hegmann KT, ed. Low back disorders. In: Glass LS, editor(s). Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2007. p. 366. North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spondylolisthesis. Burr Ridge (IL): North American Spine Society (NASS); 2008. http://www.spine.org/Documents/Spondylolisthesis_Clinical_Guideline.pdf North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spinal stenosis. Burr Ridge (IL): North American Spine Society (NASS); 2007 Jan. http://www.spine.org/Documents/NASSCG_Stenosis.pdf Acupuncture. Aetna, Last reviewed Apr 2008. http://www.aetna.com/cpb/medical/data/100_199/0135.html Chiropractic Services. Aetna, Last reviewed Oct 2007. http://www.aetna.com/cpb/medical/data/100_199/0107.html Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2007, 147(7):492-504. http://www.annals.org/cgi/content/full/147/7/492 Braddock E, Greenlee J, Hammer RE, Johnson SF, Martello MJ, O’Connell MR, Rinzler R, Snider M, Swanson MR, Tain L, Walsh G. Manual medicine guidelines for musculoskeletal injuries. California: Academy for Chiropractic Education; 2007 Apr 1. http:// www.guideline.gov/summary/summary.aspx?doc_id=10798&nbr=005626&string=%22failed+back%22 Low back pain, adult. ICSI, 2006 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

29

http://www.icsi.org/guidelines_and_more/gl_os_prot/musculo-skeletal/low_back_pain/low_back_pain__adult_5.html (See also outdated report) TA Acupuncture for Chronic Osteoarthritis Pain, Headache, and Low Back Pain - Inactivated 04/2005 http://www.icsi.org/guidelines_and_more/technology_assessment_reports/technology_assessment_reports_-_inactive/acupuncture_for_ chronic_osteoarthritis_pain__headache__and_low_back_pain_-_inactivated_04_2005.html) Chronic low back pain http://www.aafp.org/afp/20061101/bmj.html. Adapted with permission from van Tulder M, Koes B. Low back pain (chronic). Clin Evid 2006;15:419-22 Council of Acupuncture and Oriental Medicine Associates (CAOMA), Foundation for Acupuncture Research. Acupuncture and electroacupuncture. Evidence-based treatment guidelines. Calistoga (CA): Council of Acupuncture and Oriental Medicine Associates (CAOMA); 2004 Dec. 111 p. http://www.guideline.gov/summary/summary.aspx?doc_id=9343&nbr=005010& string=%22neck+pain%22 Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, et al. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. Pain Physician 2007 Jan;10(1):7-111. Available: http://www.painphysicianjournal.com/ 2007/january/2007;10;7-111.pdf. (No CAM therapies included) Buckhardt CS, Goldenberg D, Crofford L, Gerwin R, Gowens S, Jackson K, Kugel P, McCarberg W, Rudin N, Schanberg L, Taylor AG, Taylor J, Turk D. Guideline for the management of fibromyalgia syndrome pain in adults and children. Glenview (IL): American Pain Society (APS); 2005. 109 p. (Clinical practice guideline; no. 4). http://www.guideline.gov/summary/summary.aspx?ss=14& doc_id=7298&string= Neck and upper back complaints. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2004. 30 p. http://www.guideline.gov/summary/summary.aspx?doc_id=8542&nbr=004751&string=%22neck+pain%22 (No CAM therapies mentioned) Acupuncture, Consensus Development Conference Reports. NIH, 1997. http://www.ncbi.nlm.nih.gov/books/bv.fcgi? rid=hstat4.chapter.18129 Hegmann KT, ed. Low back disorders. In: Glass LS, editor(s). Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2007. p. 366. [1310 references]. Guideline summary: http://www.guideline.gov/summary/ summary.aspx?view_id=1&doc_id=12540 http://www.guideline.gov/summary/summary.aspx?doc_id=11024&nbr=005804&string= Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic). Corpus Christi (TX): Work Loss Data Institute; 2007 Jul 5. 393 p. This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary. Work Loss Data Institute (in progress). Neck and upper back (acute & chronic) International 5 items Low back pain: the acute management of patients with chronic (longer than 6 weeks) non-specific low back pain. NICE, in progress (due May 2009). http://www.nice.org.uk/nicemedia/pdf/LowBackPain_FinalScope.pdf. Consultation: http://www.nice.org.uk/guidance/ index.jsp?action=folder&o=42249. See also: http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11645 Back Pain (Low) and Sciatica. PRODIGY guidance (NHS), Last revised Sep 2008. http://www.cks.library.nhs.uk/ back_pain_low_and_sciatica. No coverage of CAM therapies New Zealand acute low back pain guide, incorporating the guide to assessing psychosocial yellow flags in acute low back pain. New Zealand Guidelines Group, 2004 http://www.nzgg.org.nz/guidelines/dsp_guideline_popup.cfm?guidelineCatID=9&guidelineID=72 European guidelines for the management of chronic non-specific low back pain. On behalf of the COST B13 Working Group on Guidelines for Chronic Low Back Pain, Nov 2004, Amended Jun 2005. http://www.backpaineurope.org/web/files/WG2_Guidelines.pdf Neck pain - Management. PRODIGY guidance (NHS), Last revised Jul 2005. http://www.cks.library.nhs.uk/neck_pain. No coverage of CAM therapies Clinical Trials

Not yet recruiting Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

30

5 items Efficacy of Different Acupuncture Methods for Chronic Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00758017? term=back+pain+backpain&rank=15 Spinal Manipulative Therapy for Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00294229?term=back+pain+backpain& rank=17 Electroacupuncture and Laser Therapy on Neck Pain. http://clinicaltrials.gov/ct2/show/NCT00618878?cond=%22Neck+Pain%22& rank=18 Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain http://clinicaltrials.gov/ct2/show/NCT00502619? cond=%22Back+Pain%22& rank=141 The effectiveness of spinal manipulative therapy (SMT) versus Graston therapy (GT) in the treatment of non-specific thoracic pain: A randomised controlled trial http://www.anzctr.org.au/ACTRN12608000070336.aspx

Recruiting 21 items Effectiveness of Manual Therapy in Patients With Neck Pain (NECKProject). http://clinicaltrials.gov/ct2/show/NCT00713843? cond=%22Neck+Pain%22&rank=8 Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization. http://clinicaltrials.gov/ct2/show/ NCT00504686?cond=%22Neck+Pain%22&rank=17 Manual and Manipulative Therapy for Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00632060?cond=%22Back+Pain%22& rank=32 The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial. http://clinicaltrials.gov/ct2/ show/NCT00315120?cond=%22Back+Pain%22& rank=40 How Does Manual Therapy Improve Low Back Pain for Soldiers? http://clinicaltrials.gov/ct2/show/NCT00394264? cond=%22Back+Pain%22& rank=50 Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy http://clinicaltrials.gov/ct2/show/NCT00571480? cond=%22Back+Pain%22& rank=58 Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00487266? cond=%22Back+Pain%22& rank=89 Individualized Chiropractic and Integrative Care for Low Back Pain http://clinicaltrials.gov/ct2/show/NCT00567333? cond=%22Back+Pain%22& rank=101 Chiropractic Management of Chronic Lower Back Pain in Older Adults http://clinicaltrials.gov/ct2/show/NCT00475787? cond=%22Back+Pain%22& rank=118 A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain http://clinicaltrials.gov/ct2/show/ NCT00732394?cond=%22Back+Pain%22& rank=123 Dose of Spinal Manipulation for Chronic Low Back Pain http://clinicaltrials.gov/ct2/show/NCT00376350? cond=%22Back+Pain%22& rank=132 Z-Joint Changes in Low Back Pain Following Adjusting http://clinicaltrials.gov/ct2/show/NCT00284063? cond=%22Back+Pain%22& rank=153 Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects http://clinicaltrials.gov/ct2/show/NCT00426244? cond=%22Back+Pain%22& rank=170 Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response http://clinicaltrials.gov/ ct2/show/NCT00601341?cond=%22Back+Pain%22& rank=258 Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip. http://clinicaltrials.gov/ ct2/show/NCT00450060?cond=%22Back+Pain%22& rank=266 Chiropractic Dosage for Lumbar Stenosis http://clinicaltrials.gov/ct2/show/NCT00527527?cond=%22Spinal+Diseases%22& intr=chiropractic&rank=1 Study to determine if laser acupuncture is of useful in the treatment of chronic low back pain. http://www.anzctr.org.au/ ACTRN12607000105448.aspx A randomised trial of the effectiveness of soft tissue massage in the treatment of shoulder pain. http://www.anzctr.org.au/ ACTRN12607000336482.aspx RCT of laser acupuncture in acute low back pain. http://www.anzctr.org.au/ACTRN12605000367640.aspx Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

31

Efficacy of manipulation for recent onset neck pain. A randomised controlled trial http://www.anzctr.org.au/ ACTRN12606000417583.aspx A clinical trial of manipulative therapy and/or NSAIDs for significant acute low back pain. http://www.anzctr.org.au/ ACTRN12605000036617.aspx

Ongoing 8 items Chiropractic and Exercise for Seniors with neck pain. http://clinicaltrials.gov/ct2/show/NCT00269308?cond=%22Neck+Pain%22& rank=5 Exploring Integrative Medicine in Swedish Primary Care. http://clinicaltrials.gov/ct2/show/NCT00565942? cond=%22Neck+Pain%22&rank=20 Effect of Massage on Chronic Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00371384?cond=%22Back+Pain%22& rank=74 Effects of Electrical Acupuncture and Exercise in Older Adults With Chronic Low Back Pain. http://clinicaltrials.gov/ct2/show/ NCT00101387?cond=%22Back+Pain%22& rank=93 Acupuncture Analgesia in Relation to Psychiatric Comorbidity http://clinicaltrials.gov/ct2/show/NCT00307788? cond=%22Back+Pain%22& rank=157 Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded http://clinicaltrials.gov/ct2/show/NCT00353847? cond=%22Back+Pain%22& rank=159 Evaluation of different types of treatments for chronic neck pain. http://www.controlled-trials.com/ISRCTN92199001 Efficacy of acupuncture for chronic low back pain. http://clinicaltrials.gov/show/NCT00065585

Completed 39 items Evaluating Therapeutic Massage for Chronic Neck Pain. http://clinicaltrials.gov/ct2/show/NCT00065416? cond=%22Neck+Pain%22&rank=1 Manipulation, Exercise, and Self-Care for neck pain. http://clinicaltrials.gov/ct2/show/NCT00269360?cond=%22Neck+Pain%22& rank=3 Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic neck pain. http://clinicaltrials.gov/ ct2/show/NCT00429624?cond=%22Neck+Pain%22&rank=4 Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain http://clinicaltrials.gov/ct2/show/NCT00128869?cond=%22Neck+Pain%22&rank=7 Chiropractic Care, Medication, and Self-Care for Neck Pain. http://clinicaltrials.gov/ct2/show/NCT00029770? cond=%22Neck+Pain%22&rank=13 Physical CAM Therapies for Chronic Low Back Pain. http://clinicaltrials.gov/ct2/show/NCT00065975?cond=%22Back+Pain%22& rank=17 Massage, Meditation, and Tai Chi for Chronic Lower Back Pain. http://clinicaltrials.gov/ct2/show/NCT00070915? cond=%22Back+Pain%22& rank=91 Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain http://clinicaltrials.gov/ ct2/show/NCT00257998?cond=%22Back+Pain%22& rank=116 Pilot Study to Test the Effectiveness of Combining Conventional and Complementary Medicine to Treat Low Back Pain http:// clinicaltrials.gov/ct2/show/NCT00118859?cond=%22Back+Pain%22& rank=133 A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique http:// clinicaltrials.gov/ct2/show/NCT00163124?cond=%22Back+Pain%22& rank=165 Effects of a Mulligan Mobilisation in the Lumbar Flexion Range of Asymptomatic Subjects http://clinicaltrials.gov/ct2/show/ NCT00678093?cond=%22Back+Pain%22& rank=172 The Use of Manual Therapy to Treat Low-Back and Hip Pain http://clinicaltrials.gov/ct2/show/NCT00410397? cond=%22Back+Pain%22& rank=174 Using MRI Scans to Evaluate Spinal Manipulation http://clinicaltrials.gov/ct2/show/NCT00070902?cond=%22Back+Pain%22& rank=196 Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women http://clinicaltrials.gov/ct2/show/ NCT00298935?cond=%22Back+Pain%22& rank=203 Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

32

Predicting Patients’ Response to Spinal Manipulation http://clinicaltrials.gov/ct2/show/NCT00285649?cond=%22Back+Pain%22& rank=206 The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures http://clinicaltrials.gov/ct2/show/ NCT00739570?cond=%22Back+Pain%22& rank=208 Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial http://clinicaltrials.gov/ct2/show/ NCT00415220?cond=%22Sciatica%22&rank=7 Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine (ACP) http:// clinicaltrials.gov/ct2/show/NCT00635037?cond=%22Myofascial+Pain+Syndromes%22& rank=112 Acupuncture in Fibromyalgia ??Myofascial Pain? http://clinicaltrials.gov/ct2/show/NCT00010504? cond=%22Myofascial+Pain+Syndromes%22& rank=12 Trial of Acupuncture Added to Usual Treatment for Fibromyalgia ??Myofascial Pain? http://clinicaltrials.gov/ct2/show/NCT00379496? cond=%22Myofascial+Pain+Syndromes%22& rank=21 Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia ??Myofascial Pain? http://clinicaltrials.gov/ct2/show/ NCT00142597?cond=%22Myofascial+Pain+Syndromes%22& rank=108 Acupuncture for chronic neck pain: a pilot for a randomised controlled trial. http://www.controlled-trials.com/ISRCTN06223266 Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain. http://www.controlled-trials.com/ISRCTN81350628 Exercise and manual auricular acupuncture: a single-blind, feasibility, randomised controlled trial exploring the effectiveness of a combined approach for chronic low back pain. http://www.controlled-trials.com/ISRCTN94142364 Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial. http://www.controlled-trials.com/ISRCTN65814467 A randomised pilot study: does the addition of acupuncture to back fitness and education reduce disability in chronic low back pain?. http://www.controlled-trials.com/ISRCTN13737091 A randomised factorial trial for patients with recurrent and chronic back pain of GP exercise prescription, the Alexander Technique and massage. http://www.controlled-trials.com/ISRCTN26416991 The UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists Low back pain Management trial (COMPLEMENT Trial). http://www.controlled-trials.com/ISRCTN77245761 Naprapathy or evidence based care provided by a physician for patients with non-specific low back and/or neck/shoulder pain: a randomised controlled trial. http://www.controlled-trials.com/ISRCTN56954776 The effectiveness of manual therapy or pulsed shortwave diathermy (PSWD) in addition to exercise and advice for neck disorders; a pragmatic study in physiotherapy clinics. http://www.controlled-trials.com/ISRCTN77535030 Evaluating the effect of therapeutic massage in side-to-side weight-bearing symmetry in subjects with lower back pain (single blind study). http://www.controlled-trials.com/ISRCTN70913537 A Pilot Study Comparing Frequency and Style of Acupuncture for Chronic Low Back Pain. http://www.controlled-trials.com/ ISRCTN41571810 The UK Back pain, Exercise Active management and Manipulation trial. http://www.controlled-trials.com/ISRCTN32683578 A Randomised Controlled Trial (RCT) of the effect on chronic low back pain of a naturopathic osteopathy intervention. http:// www.controlled-trials.com/ISRCTN61808774 Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain. http://www.controlledtrials.com/ISRCTN80764175 Acupuncture as a complement to standard treatment for the treatment of well-defined pelvic girdle pain in pregnant women. http:// isrctn.org/ISRCTN11374571 Randomised controlled trial (RCT) comparing long term effect of exercise to rehabilitate spinal stabilisation, manual therapy & an education booklet in the treatment of chronic back pain. http://www.controlled-trials.com/ISRCTN53815070 The efficacy of acupuncture versus local anaesthetic injection in the treatment of myofascial pain in the jaw muscles. http:// www.controlled-trials.com/ISRCTN22866867 Manipulative Therapy added on Usual Medical Care in patients with shoulder pain and dysfunction: a randomized controlled trial. http://isrctn.org/ISRCTN86183481

Economics 4 items Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

33

Service delivery organization for acute low back pain. NHS Quality Improvement Scotland. http://www.nhshealthquality.org/nhsqis/ files/Master%20Report%20191207.pdf Utilization of health services in a publicly funded health care system: the example of musculoskeletal disorders [project], ICES. http:// www.ices.on.ca/webpage.cfm?site_id=1&org_id=2&morg_id=0&gsec_id=4311&item_id=4311&category_id=46 Cost-Effectiveness of Complementary Therapies in the United Kingdom-A Systematic Review. Evidence-Based Complementary and Alternative Medicine, 2006. http://ecam.oxfordjournals.org/cgi/content/full/3/4/425 Lawrence VA, Tugwell P, Gafni A, Kosuwon W, Spitzer WO. Acute low back pain and economics of therapy: the iterative loop approach. Journal of Clinical Epidemiology 1992;45(3):301-11.. http://www.ncbi.nlm.nih.gov/pubmed/1533245

Safety 3 items The safety of massage therapy. Rheumatology 2003;42:1101-6 http://rheumatology.oxfordjournals.org/cgi/content/full/42/9/1101 Adverse effects of spinal manipulation: a systematic review. J R Soc Med 2007;100:330-8. http://jrsm.rsmjournals.com/cgi/content/ full/100/7/330 Harm from acupuncture. Bandolier, date? http://www.medicine.ox.ac.uk/bandolier/band68/b68-4.html

Critical Appraisals 1 item Snelling NJ. Spinal manipulation in patients with disc herniation: a critical review of risk and benefit. http://www.crd.york.ac.uk/ CRDWeb/ShowRecord.asp?ID=12006008579

Miscellaneous 26 items Annual evidence update on complementary and alternative medicine for low back pain. Complementary and Alternative Medicine Specialist Library, Sep 2008 Update. http://www.library.nhs.uk/cam/ViewResource.aspx?resID=292622&tabID=289 Cervicalgia - Diagnosis and Therapy [project]. Belgian Health Care Knowledge Centre. http://www.kce.fgov.be/index_en.aspx? SGREF=5225&CREF=10208 This study aims to develop evidence based guidelines for diagnosis and treatment of acute and chronic neck pain. These guidelines target professional caretakers (general practitioners, specialists, physiotherapists, pain centres), as well as patients, the public at large and the policy makers Managing Injuries of the Neck Trial (MINT) [project]. NCCHTA, publication date late 2009. http://www.ncchta.org/project/1399.asp Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin [project]. NCCHTA, publication date Feb 2009. http:// www.ncchta.org/project/1677.asp What is the effectiveness of laser acupuncture in patients with chronic pain, relative to other forms of pain relief? ARIF, 2008. http:// www.arif.bham.ac.uk/l/laser-acupuncture-chronic-pain.shtml Does acupuncture reduce pain in adults with acute or chronic low back pain? [Evidence review]. NZ Complementary and Alternative Medicine Web site, Last updated 2006 Aug 8. http://www.cam.org.nz/Treatment%20Methods/Acupuncture/ Acupuncture%20low%20back%20pain%20Evidence%20review%20- %20%2003%20Aug%2006.htm Does chiropractic treatment help with low-back pain? NZ Complementary and Alternative Medicine Web site, Last updated 2006 Aug 8. http://www.cam.org.nz/Treatment%20Methods/ Chiropractic/Chiropractic%20low%20back%20pain%20Evidence%20review%20- %20%2008%20Aug%2006.htm Spinal manipulation for chronic (long term) back pain. NZ Complementary and Alternative Medicine Web site, Last updated 2004 Mar 25. http://www.cam.org.nz/Treatment%20Methods/Chiropractic/back_pain_chronic.htm What are the symptoms of whiplash injury and what is the management? ATTRACT, 2003 http://www.attract.wales.nhs.uk/ question_answers.cfm?question_id=1288 Is there any evidence confirming the effectiveness of osteopathy/chiropractors in the management of mechanical/degenerative back pain? ATTRACT, 2003. http://www.attract.wales.nhs.uk/question_answers.cfm?question_id=1526 Spinal manipulation - No better than other treatments for chronic low back pain. VATAP, 2003. http://www.research.va.gov/resources/ pubs/docs/hsr_brief_no10.pdf Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

34

What is the most efficacious method of treating sciatica and/ or lower back pain? ATTRACT, 2001. http://www.attract.wales.nhs.uk/ question_answers.cfm?question_id=311 Is the outcome for patients with low back pain influenced by GP’s referral for plain radiography. NCCHTA, 2000. http:// www.ncchta.org/project/894.asp Spinal manipulation reviewed. Bandolier, 2006. http://www.medicine.ox.ac.uk/bandolier/band147/b147-8.html Acupuncture for neck and back pain. Bandolier, 2000. http://www.medicine.ox.ac.uk/bandolier/booth/alternat/CP097.html Acupuncture for back pain? Bandolier, date? http://www.medicine.ox.ac.uk/bandolier/band60/b60-2.html Back Pain. Bandolier, date? http://www.medicine.ox.ac.uk/bandolier/band19/b19-1.html Massage for low back pain. Bandolier, 2000. http://www.medicine.ox.ac.uk/bandolier/booth/alternat/AT042.html Effectiveness of massage. Bandolier, 2000. http://www.medicine.ox.ac.uk/bandolier/booth/alternat/AT045.html Cervical spine manipulation and mobilisation for neck pain and headache. Bandolier, 2000. http://www.medicine.ox.ac.uk/bandolier/ booth/alternat/CP095.html Chiropractic for low back pain. Bandolier, 1999. http://www.medicine.ox.ac.uk/bandolier/booth/painpag/Chronrev/muscskel/ CP092.html Spinal manipulation and mobilisation for low back pain. Bandolier, 1999. http://www.medicine.ox.ac.uk/bandolier/booth/painpag/ Chronrev/muscskel/CP094.html Hirschkorn K, Bourgeault IL. Actions Speak Louder than Words: Mainstream Health Providers’ Definitions and Behaviour Regarding Complementary and Alternative Medicine. Complementary Therapies in Clinical Practice 2007;13(1):29-37. http:// www.ncbi.nlm.nih.gov/pubmed/17210509 Hirschkorn K, Bourgeault IL. Actions Speak Louder than Words: Mainstream Health Providers’ Definitions and Behaviour Regarding Complementary and Alternative Medicine. Social Science & Medicine 2005;61:157-170. Whiplash: ‘why pay for what does not work?’ J Musculoskeletal Pain 2000;8(1-2):29-53. http://www.haworthpress.com/store/ ArticleAbstract.asp?sid=8G7HFJV9SK1A8MG7S94FWS3GWPSC5MNE& ID=40271 Aker P, Birch S. et al. An evidence-based approach to the management of low back injuries. Submitted to the Workers’ Compensation Board of Ontario, 1997. (no link available)

Appendix 5. Sources of Risk of Bias 1. Random sequence generation. (selection bias) There is a low risk of selection bias if a random (unpredictable) assignment sequence was used. Examples of low risk methods are: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). Examples of high risk methods are: alternation, birth date, social insurance/security number, date in which they are invited to participate in the study, or hospital registration number 2. Allocation concealment. (selection bias) There is a low risk of selection bias if the assignment was generated by an independent person not responsible for determining the eligibility of the patients. This person had no information about the persons included in the trial, no influence on the assignment sequence or eligibility of the patient, and could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based, and pharmacy-controlled, randomization); sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, or sealed envelopes. Examples of high risk methods are: using an open random allocation schedule (e.g. a list of random numbers), assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered), alternation or rotation, date of birth, case record number, or other explicitly unconcealed procedure. Knowledge of the allocated interventions was adequately prevented during the study. (performance bias) 3. Blinding of participants. (performance bias) There is a low risk of performance bias if the index and control groups were indistinguishable for the patients, the success of blinding was tested among the patients and it was successful, or the outcome measurements were not likely to be influenced by lack of blinding. 4. Blinding of personnel. (performance bias) There is a low risk of performance bias if the index and control groups were indistinguishable for the care providers, the success of blinding was tested among the care providers and it was successful, or the outcome measurements were not likely to be influenced by lack of blinding. Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

35

5. Blinding of outcomes assessment. (detection bias) Adequacy of blinding should be assessed for the primary outcomes. There is low risk of detection bias if the success of blinding was tested among the outcome assessors and it was successful, or: • for patient-reported outcomes in which the patient was the outcome assessor (e.g., pain, disability): there is a low risk of bias for outcome assessors if there is a low risk of bias for participant blinding. • for outcome criteria assessed during scheduled visit and that supposes a contact between participants and outcome assessors (e.g., clinical examination): there is a low risk of bias for patients and the treatment or adverse effects of the treatment could not be noticed during clinical examination. • for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (e.g., treatment failure), in which the care provider is the outcome assessor: there is a low risk of bias for outcome assessors if there is a low risk of bias for care providers. • for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the treatment could not be noticed in the extracted data. Incomplete outcome data. (attrition bias) 6. The drop-out rate was described and acceptable. The number of participants who were included in the study but did not complete the observation period or were not included in the analysis must be described and reasons given. There is a low risk of attrition bias if there were no missing data, reasons for missing outcome data were unlikely to be related to the true outcome (for survival data, censoring unlikely to be introducing bias), missing outcome data were balanced in numbers, with similar reasons for missing data across groups, the percentage of withdrawals and drop-outs did not exceed 20% for short-term follow-up and 30% for long-term follow-up and did not lead to substantial bias (Note: these percentages are arbitrary, not supported by literature). For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate; for continuous outcome data, the plausible effect size (difference in means or standardized difference in means) among missing outcomes was not enough to have a clinically relevant impact on observed effect size, or missing data were imputed using appropriate methods (Note: if drop-outs are very large, even imputation using “acceptable” methods may still suggest a high risk of bias) 7. All randomised participants were analysed in the group to which they were allocated. (attrition bias) There is low risk of attrition bias if all randomised patients were reported/analyzed in the group to which they were allocated by randomisation for the most important moments of effect measurement (minus missing values), regardless of non-compliance and cointerventions. 8. Selective reporting. (reporting bias) There is low risk of reporting bias if the results from all pre-specified outcomes have been adequately reported in the published report of the trial. This information is either obtained by comparing the protocol and the report, or in the absence of the protocol, assessing that the published report includes enough information to make this judgment. There is a high risk of reporting bias if one or more outcomes of interest is not measured or reported as pre-specified, is not reported or is reported incompletely so that data cannot be entered in a meta-analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study. Other sources of potential bias: 9. Important prognostic indicators at baseline. There is low risk of bias if groups are similar at baseline for demographic factors, duration and severity of complaints, percentage of patients with neurological symptoms, or value of main outcome measure(s). 10. Co-interventions. There is low risk of bias if there were no co-interventions or they were similar between the index and control groups. 11. Compliance. There is low risk of bias if compliance with the interventions was acceptable, based on the reported intensity, duration, number and frequency of sessions for both the index and control intervention(s). For example, since physiotherapy treatment is usually administered over several sessions, it is important to assess how many sessions each patient attended. For single-session interventions (e.g., surgery), this item is irrelevant. 12. Timing of the outcome assessment across groups. There is low risk of bias if all important outcome assessments for all intervention groups were measured at the same time. 13. Other bias. There is a low risk of bias if the study appears to be free of other sources of bias not addressed elsewhere (e.g., study funding). Acupuncture for (sub)acute non-specific low-back pain (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

36

Appendix 6. Grading of Evidence

Grade

Domain

High

All 4 domains are met (e.g., low risk of bias, precise, direct, consistent). Further research is unlikely to change either the estimate or our confidence in the results

Moderate

1 of the domains is not met. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate

Low

2 to 4 of the domains are not met. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate

Insufficient

No evidence/absence of evidence.

CONTRIBUTIONS OF AUTHORS All authors contributed to the conception and design of this protocol.

DECLARATIONS OF INTEREST No review authors have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this review.

SOURCES OF SUPPORT Internal sources • No sources of support supplied

External sources • Agency for Healthcare Research and Quality U.S. Department of Health and Human Services, USA. Contract No. 290-2007-10059-I (EPCIII)


37