Disability and Rehabilitation
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Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review Amanda Hall, Helen Richmond, Bethan Copsey, Zara Hansen, Esther Williamson, Gillian Jones, Beth Fordham, Zafra Cooper & Sarah Lamb To cite this article: Amanda Hall, Helen Richmond, Bethan Copsey, Zara Hansen, Esther Williamson, Gillian Jones, Beth Fordham, Zafra Cooper & Sarah Lamb (2016): Physiotherapistdelivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review, Disability and Rehabilitation, DOI: 10.1080/09638288.2016.1236155 To link to this article: http://dx.doi.org/10.1080/09638288.2016.1236155
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Date: 23 November 2016, At: 05:14
DISABILITY AND REHABILITATION, 2016 http://dx.doi.org/10.1080/09638288.2016.1236155
REVIEW ARTICLE
Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review Amanda Halla,b, Helen Richmondb, Bethan Copseyb, Zara Hansenb, Esther Williamsonb, Gillian Jonesb, Beth Fordhamb, Zafra Cooperc and Sarah Lambb a The George Institute for Global Health, Oxford Martin School, University of Oxford, Oxford, UK; bNuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK; cDepartment of Psychiatry, University of Oxford, Oxford, UK
ABSTRACT
ARTICLE HISTORY
Purpose: To determine if physiotherapist-led cognitive-behavioural (CB) interventions are effective for low back pain (LBP) and described sufficiently for replication. Method: Randomised controlled trials (RCTs) of patients with LBP treated by physiotherapists using a CB intervention were included. Outcomes of disability, pain, and quality of life were assessed using the GRADE approach. Intervention reporting was assessed using the Template for Intervention Description and Replication. Results: Of 1898 titles, 5 RCTs (n ¼ 1390) were identified. Compared to education and/or exercise interventions, we found high-quality evidence that CB had a greater effect (SMD; 95% CI) on reducing disability (0.19; 0.32, 0.07), pain (0.21; 0.33, 0.09); and moderate-quality evidence of little difference in quality of life (0.06; 0.18 to 0.07). Sufficient information was provided on dose, setting, and provider; but not content and procedural information. Studies tended to report the type of CB component used (e.g., challenging unhelpful thoughts) with little detail on how it was operationalised. Moreover, access to treatment manuals, patient materials and provider training was lacking. Conclusions: With additional training, physiotherapists can deliver effective CB interventions. However, without training or resources, successful translation and implementation remains unlikely. Researchers should improve reporting of procedural information, provide relevant materials, and offer accessible provider training.
Received 10 May 2016 Revised 6 September 2016 Accepted 9 September 2016 KEYWORDS
Physical activity; rehabilitation; implementation
ä IMPLICATIONS FOR REHABILITATION
Previous reviews have established that traditional biomedical-based treatments (e.g., acupuncture, manual therapy, massage, and specific exercise programmes) that focus only on physical symptoms do provide short-term benefits but the sustained effect is questionable. A cognitive-behavioural (CB) approach includes techniques to target both physical and psychosocial symptoms related to pain and provides patients with long-lasting skills to manage these symptoms on their own. This combined method has been used in a variety of settings delivered by different health care professionals and has been shown to produce long-term effects on patient outcomes. What has been unclear is if these programmes are effective when delivered by physiotherapists in routine physiotherapy settings. Our study synthesises the evidence for this context. We have confirmed with high-quality evidence that with additional training, physiotherapists can deliver CB interventions that are effective for patients with back pain. Physiotherapists who are considering enhancing their treatment for patients with low back pain should consider undertaking some additional training in how to incorporate CB techniques into their practice to optimise treatment benefits and help patients receive long-lasting treatment effects. Importantly, our results indicate that using a CB approach, including a variety of CB techniques that could be easily adopted in a physical therapy setting, provides greater benefits for patient outcomes compared to brief education, exercise or physical techniques (such as manual therapy) alone. This provides further support that a combined treatment approach is likely better than one based on physical techniques alone. Notably, we identified a significant barrier to adopting any of these CB interventions in practice. This is because no study provided a description of the intervention or accessible training materials that would allow for accurate replication. Without access to provider training and/or resources, we cannot expect this evidence to be implemented in practice with optimal effects. Thus, we would urge physiotherapists to directly contact authors of the studies for more information on how to incorporate their interventions into their settings.
CONTACT Amanda Hall
[email protected] Street, Oxford OX1 3BD, UK Supplemental data for this article can be accessed here. ß 2016 Informa UK Limited, trading as Taylor & Francis Group
The George Institute for Global Health, Oxford Martin School, University of Oxford, 34 Broad
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A. HALL ET AL.
Introduction Low back pain (LBP) has an annual prevalence of 37% in the UK and carries one of the greatest disability burdens in the world.[1] The condition is described as episodic in nature and impacts on people’s ability to work and perform everyday tasks, placing substantial demand on society and the economy.[2–4] It is well documented that in addition to pain and disability, patients seeking care for their back pain can present with fear-avoidance beliefs, stress, and low confidence to self-manage their pain symptoms.[5,6] Clinical practice guidelines for LBP promote the use of a biopsychosocial approach including cognitive-behavioural (CB) interventions – a treatment model that targets psychological and physical factors.[7] While CB interventions have been shown to be effective,[8] the use of this approach is still the largest gap in UK LBP services.[9] This evidence–practice gap is likely due to a lack of clear information on how best to integrate CB techniques into routine clinical practice such as physiotherapy settings, where the majority of LBP patients receive treatment. Cognitive-behavioural therapy (CBT), which is based on a model of the relationships between thoughts and behaviour, was originally developed as a means of treating people with depression and has been successfully extended to treat a range of psychological disorders.[10,11] Training in CBT to treat emotional disorders is relatively lengthy and specialised and as such access to treatment is limited by the availability of suitably trained therapists. Previous research on the prognosis of LBP has identified that how patients perceive their LBP problems and what they do to cope with them are associated with their clinical outcomes (i.e., pain and disability).[12–14] Accordingly, an approach to the treatment of LBP using a range of CB techniques (e.g., using a guided discovery delivery style, assessing thoughts and challenging unhelpful thoughts, goal setting, activity pacing, graded activity, problem-solving, and homework) has been shown to be effective when incorporated into specialised pain management programmes delivered by trained health care professionals (HCPs).[8,15] However, pain management programmes often require a large number of treatment hours delivered by a multidisciplinary team of HCPs and as such are costly and not widely available across health care settings, limiting direct access for patients with LBP.[15] Physiotherapists are a common provider of treatment for LBP in primary care settings including hospital and community-based outpatient departments [4] where access to psychological services or specialised pain management programmes tends to be limited. Thus, training physiotherapists to deliver a CB approach within primary care is likely to increase the probability of patients receiving care in line with guidelines. No previous systematic review has established the effectiveness of CB interventions when delivered by physiotherapists in routine clinical practice.[8,11,16] Moreover, previous systematic reviews have not assessed whether CB interventions are reported in sufficient detail to allow replication in clinical practice.[17] To improve the quality of the evidence for implementation purposes, the Medical Research Council (MRC) and the Appraisal of Guidelines for REsearch and Evaluation (AGREE) group recommend that the practice context (e.g., factors such as intervention setting and resource implications) be taken into consideration. Therefore, to provide evidence applicable to routine physiotherapy settings such as those that are publically funded, our review focused on the effectiveness of physiotherapist-led CB programmes delivered in routine primary care outpatient departments.[17,18] The research objectives for this study were: (i) to determine the effectiveness of CB interventions delivered by physiotherapists
as part of routine clinical practice in a primary care setting and (ii) to assess whether study interventions found to be effective are described sufficiently to enable replication by physiotherapists in routine clinical care.
Methods Identification and selection of studies Databases and search strategy Eligible studies were identified using an extensive search strategy of key terms: low back pain, cognitive behavioural interventions, and randomised controlled trials in several databases (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED, Physiotherapy Evidence Database (PEDro), the Cochrane Back Review Group (CBRG) Trials Register, PsycINFO, and OpenGrey) from inception to July 2016 (Supplemental Table S1). All titles were independently screened for inclusion by two authors (A.H., B.C.) and any disagreements were resolved by consensus or further consultation with a third author (H.R. or Z.H.). Selection of studies Participants Studies were included if patients had non-specific LBP of any duration. Studies were excluded if the participants had serious spinal pathology such as fracture or nerve root compression. Intervention Studies were included if the intervention was based on the CB model and primarily included strategies to change maladaptive thoughts and behaviours related to pain and physical activity. To ensure similar contexts and resource implications, interventions had to be delivered by a physiotherapist within a hospital or community-based physiotherapy outpatient department. Studies were excluded if the intervention (i) did not include CB strategies as a primary component of the treatment, (ii) was delivered by another health professional or a multidisciplinary team of health professionals and, (iii) was conducted in private physiotherapy clinics or specialist pain centres, where funding, staff, and resource structures are likely to be different to typical publically-funded physiotherapy outpatient clinics. Comparison Studies were included if the comparison group was: (i) a waitlist control, (ii) no treatment control, (iii) treatment as usual control, or (iv) another active treatment. The treatment as usual condition was defined as one in which patients were not provided with a formal package of treatment from the study providers but were free to seek care as they would normally. Active treatment was defined as any intervention recommended in the European Guidelines for LBP.[7] Studies in which the comparison group was a passive, pharmacological, or invasive intervention such as surgery or medication were outside the focus of this review and were excluded. Outcome measures The primary outcome of interest was pain-related disability, measured using patient self-report questionnaires including the Roland Morris Disability Questionnaire (RMDQ), Oswestry, or similar. Secondary outcomes included pain measured with the Numerical Rating Scale (NRS) or Visual Analogue Scale (VAS) and quality of life measured with the European Quality of Life Scale (EQ-5D) or Short-Form Health Survey (SF-12). We split outcomes into short-
PHYSIOTHERAPIST COGNITIVE-BEHAVIOURAL TREATMENT
term (3-month follow-up or less) and long-term (12 months or more). We considered long-term outcomes as the primary outcome for this review. Data extraction Study characteristics For all included studies, two authors independently extracted data on treatment outcomes (A.H., B.C.), study-level characteristics (A.H., H.R.), and intervention details (H.R., Z.H.). Specifically, intervention information was extracted using the Template for Intervention Description and Replication (TIDieR) [17]; including name, rationale, materials, procedures, provider, how and where it was delivered, dose, tailoring and modifications, and intervention fidelity. Where necessary, further details were requested from authors or obtained from additional published documents such as trial protocols. Any discrepancies in data extraction were resolved via consensus. Quality Risk of bias was assessed using the 12-point Cochrane risk of bias (RoB) tool: (i) random sequence generation, (ii) allocation concealment, blinding of (iii) participants, (iv) providers, and (v) assessors, (vi) incomplete outcome data, (vii) intention to treat analysis, (viii) selective reporting, (ix) baseline prognostic indicators, (x) co-interventions, (xi) compliance, and (xii) timing of outcome assessment. Overall risk of bias was assessed using scores from five of the items (items ii, iii, v, vi, and vii); studies rated as low on 3 or more of these items were judged to have low risk of bias. The GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was used to assess overall quality of the evidence.[19] Quality was downgraded based on four factors; (i) methodological quality: downgraded if 25% or more of the participants were from studies rated as having a high risk of bias, (ii) inconsistency in the results: downgraded if >25% of participants were from studies with visual differences in direction of effect; (iii) indirectness of evidence: downgraded if more than 50% of the participants were outside the target group, and (iv) imprecision of evidence: downgraded if fewer than 400 participants were included in the comparison. Additionally, for outcomes with only a single study with fewer than 400 participants, evidence was downgraded. We reduced the quality of the evidence for a specific outcome by one level, according to these five factors and described them using the 5 GRADE categories: high-quality evidence: there are consistent findings among at least 75% of randomised controlled trials (RCTs) with low risk of bias, consistent, direct, and precise data and no known or suspected publication biases. Further research is unlikely to change either the estimate or our confidence in the results; moderate-quality evidence: one 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-quality evidence: two 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; very low-quality evidence: three of the domains are not met. We are very uncertain about the results; no evidence: no RCTs were identified that addressed this outcome. Data analysis Two main contrasts were used: CB intervention versus (i) no treatment (including waitlist or treatment as usual) and (ii) active treatment. Studies that included a contrast of CB þ active treatment
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versus the active treatment would be included in the second contrast unless statistical heterogeneity was observed. Meta-analyses were performed using a random effects model.[20] Pooled treatment effects were calculated as standardised mean difference (SMD) for pain, disability, and quality of life outcomes. Where applicable, scales were reversed by subtracting the mean score from the scale maximum. A negative SMD indicated a treatment effect in favour of the CB intervention. Effect sizes proposed by Cohen were used with 0.2 representing a small effect, 0.5 a moderate effect, and 0.8 a large effect.[21] Statistical heterogeneity was assessed using the I2 statistic and interpreted as: may not be important if 0–40%, may represent moderate heterogeneity if 30–60%, may represent substantial heterogeneity if 50–90% and high heterogeneity if 75–100%. Additionally, if significant clinical heterogeneity was observed in intervention or comparison treatments, sub-group analyses were performed to assess whether these differences influenced the treatment effect.
Results Flow of studies through the review Of the 1898 identified trials, 25 studies were RCTs comparing CB to a waiting-list control, usual care, or another active treatment. Of these, only 5 studies [5,22–25] were delivered by physiotherapists in a hospital or community-based physiotherapy outpatient setting and were therefore included in this review (Figure 1). Characteristics of included studies None of the studies included a waiting-list, no treatment or treatment as usual comparison. All studies compared a CB intervention to an active treatment (including standard physiotherapy interventions or a single education session of self-management advice and exercises). All studies included patients with non-specific (NS) LBP 6-week duration, and two studies [5,24] posed additional criteria (e.g., having higher pain severity and specific psychosocial symptoms) as a means of targeting treatment to specific subgroups of patients to maximise benefits. A description of the included studies can be found in Table 1. Methodological quality Figure 2 depicts the risk of bias ratings on the 12 items for each study. Based on the 5 key items, 4 were rated as having low risk of bias [5,22,23,25] and 1 was rated as having high risk of bias.[24] Common items that received ratings of high or unclear risk of bias were subject and practitioner blinding. These ratings are for outcomes assessed at long-term. For short-term outcomes, there were only two studies included in the analysis.[23,25] For one of the two studies,[25] the methodological quality at short-term was different to its rating at long-term, it was rated as high at shortterm because of a high percentage of loss to follow-up on the short-term outcomes assessments. Physiotherapist delivered CB interventions versus active treatment in primary care settings All five RCTs [5,22–25] compared the effect of physiotherapist delivered CB interventions and active treatments. All studies assessed outcomes at long-term and two [23,25] also assessed outcomes at short-term. The pilot study by Johnstone [24] did not provide data in a usable format and was not included for analysis.
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Figure 1. Flow of studies through the review.
Table 1. Characteristics of included studies. Study Year Country Critchley 2007 UK
Age, M (SD) Pain (weeks) 44 (12.36) 12 weeks
Intervention comparison(s) CB Spinal Stability Physiotherapy
n 69 72 71
Mode (provider) Group (PT) Group (PT) Group (PT)
Duration (weeks) Contact time (h) 8 weeks/12 h 8 weeks/9 h Weeks unclear/6 h
Hill 2011 UK
49.8 (14.77) 6 weeks
CB Physiotherapy
157 79
Individual (PT) Individual (PT)
12 weeks/3.5 h 12 weeks/3 h
Johnson 2007 UK
47.9 (11.05) 12 weeks
CB þ Control Advice
116 118
Group (PT) Individual (n/a)
6 weeks/16 h n/a
Johnstone 2004 UK Lamb 2010/2012 UK
44.7 (13.2)
