Carpal Tunnel Syndrome. Part II - Archives of Physical Medicine and

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REVIEW ARTICLE (META-ANALYSIS)

Carpal Tunnel Syndrome. Part II: Effectiveness of Surgical Treatments—A Systematic Review Bionka M. Huisstede, PhD, Manon S. Randsdorp, MD, J. Henk Coert, MD, PhD, Suzanne Glerum, MD, Marienke van Middelkoop, PhD, Bart W. Koes, PhD ABSTRACT. Huisstede BM, Randsdorp MS, Coert JH, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part II: effectiveness of surgical treatments—a systematic review. Arch Phys Med Rehabil 2010;91:1005-24. Objective: To present an evidence-based overview of the effectiveness of surgical and postsurgical interventions to treat carpal tunnel syndrome (CTS). Data Sources: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were searched for relevant systematic reviews and randomized controlled trials (RCTs). Study Selection: Two reviewers independently applied the inclusion criteria to select potential studies. Data Extraction: Two reviewers independently extracted the data and assessed the methodologic quality. Data Synthesis: A best-evidence synthesis was performed to summarize the results of the included studies. Two reviews and 25 RCTs were included. Moderate evidence was found in favor of surgical treatment compared with splinting or antiinflammatory drugs plus hand therapy in the midterm and long term, and for the effectiveness of corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release in the short term. Limited evidence was found in favor of a double-incision technique compared with the standard incision technique. Also, limited evidence was found in favor of a mini-open technique assisted by a Knifelight instrument compared with a standard open release at 19 months of followup. However, in the short term and at 30 months of follow-up, no significant differences were found between the mini-open technique assisted by a Knifelight instrument compared with a standard open release. Many studies compared different surgical interventions, but no evidence was found in favor of any one of them. No RCTs explored the optimal timing strategy for surgery. No evidence was found for the efficacy of various presurgical or postsurgical treatment programs, including splinting. Conclusions: Surgical treatment seems to be more effective than splinting or anti-inflammatory drugs plus hand therapy in the midterm and long term to treat CTS. However, there is no unequivocal evidence that suggests one surgical treatment is more effective than the other. More research is needed to study conservative to surgical treatment in which also should be taken into account the optimal timing of surgery. Future re-

From the Department of General Practice (Huisstede, Randsdorp, Glerum, van Middelkoop, Koes), Department of Rehabilitation Medicine (Huisstede, Randsdorp), and Department of Plastic Reconstructive Hand Surgery (Coert), Erasmus Medical Center, Rotterdam, The Netherlands. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. Reprint requests to Bionka M. Huisstede, PhD, Erasmus Medical Center– University Medical Center Rotterdam, Dept of Rehabilitation Medicine, Room H-016, PO Box 2040, 3000 CA Rotterdam, The Netherlands, e-mail: [email protected]. 0003-9993/10/9107-00942$36.00/0 doi:10.1016/j.apmr.2010.03.023

search should also concentrate on optimal presurgical and postsurgical treatment programs. Key Words: Carpal tunnel syndrome; General surgery; Rehabilitation; Review [publication type]; Treatment outcome. © 2010 by the American Congress of Rehabilitation Medicine ARPAL TUNNEL SYNDROME is the most common C entrapment neuropathy of the 6 specific neuropathies mentioned in the Complaints of the Arm, Neck and/or Shoulder (CANS) model: measurement in the adult population (age 25–74y) showed, for example, that 5.8% of the women and 0.6% of the men are affected.1,2 Sustained or intermittent high pressure in the carpal tunnel impairs microvascular circulation in the median nerve and causes spurious generation of action potentials, local demyelination, and ultimately axonal loss.3 As a result, patients report a history of nocturnal pins and needles, and numbness and/or pain in the median nerve innervated area of the fingers, which often causes the patient to wake at night.4 The occurrence of CTS is associated with high levels of hand-arm vibration, prolonged work with a flexed or extended wrist, high requirements for hand force, high repetitiveness, and their combinations.5 The diagnosis of carpal tunnel is mainly based on its characteristics symptoms. Some clinicians decide to confirm their findings by electrophysiological examination. Provocation tests do not necessarily contribute to the clinical diagnosis of CTS.6 Various conservative and surgical strategies are used to treat CTS. Part I of this study7 concentrated on the effectiveness of conservative interventions to treat CTS and is reported separately. Surgery may be indicated when conservative treatment fails. Surgery is usually reserved for patients with severe symptoms.8 The basic principle of carpel tunnel surgery is to increase the volume of the carpal tunnel temporarily by dividing transverse carpal ligament to release the pressure on the median nerve.9 Two surgical approaches are used to establish the release of the transverse carpal ligament: open and endoscopic treatment (1-portal10,11 or 2-portal12,13 technique). Over time, several variations in techniques have been introduced to increase the success rate of carpel tunnel surgery by reducing postoperative pain and limited function, and shortening recovery time, for

List of Abbreviations CI CTS MD OR RCT RR VAS WMD

confidence interval carpal tunnel syndrome mean difference odds ratio randomized controlled trial relative risk visual analog scale weighted mean difference

Arch Phys Med Rehabil Vol 91, July 2010

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EFFECTIVENESS OF SURGICAL TREATMENTS FOR CARPAL TUNNEL SYNDROME, Huisstede Table 1: Methodologic Quality Criteria: Sources of Risk of Bias Item

Judgment

1. Was the method of randomization adequate? 2. Was the treatment allocation concealed? Was knowledge of the allocated interventions adequately prevented during the study? 3. Was the patient blinded to the intervention? 4. Was the care provider blinded to the intervention? 5. Was the outcome assessor blinded to the intervention? Were incomplete outcome data adequately addressed? 6. Was the dropout rate described and acceptable? 7. Were all randomized participants analyzed in the group to which they were allocated? 8. Are reports of the study free of suggestion of selective outcome reporting? Other sources of potential bias: 9. Were the groups similar at baseline regarding the most important prognostic indicators? 10. Were co-interventions avoided or similar? 11. Was the compliance acceptable in all groups? 12. Was the timing of the outcome assessment similar in all groups?

Yes / No / Unsure Yes / No / Unsure

example by adding tenosynovectomy or transverse carpal ligament reconstruction.3 Further, all types of postoperative interventions are used with the same goal. The purpose of Part II of this study is to present an overview of the effectiveness of surgical and postsurgical treatments for the management of CTS. Together with the related overview on the effectiveness of conservative treatments (Part I), this may help health professionals to choose the most appropriate evidence-based treatment strategies. METHODS Search Strategy A search of relevant systematic reviews on CTS was performed in the Cochrane Library. In addition, relevant review publications and RCTs in PubMed, EMBASE, CINAHL, and PEDro were searched (1) for interventions included in the systematic reviews from the date of the search strategy of the review up to January 2010 (ie, recent RCTs) and (2) from the beginning of the database up to January 2010 (ie, additional RCTs). Keywords related to the disorder such as “carpal tunnel syndrome,” “median nerve entrapment,” and “interventions” were included in the literature search. The complete search strategy is available on request. Inclusion Criteria Systematic reviews and/or RCTs were considered eligible for inclusion if they fulfilled all of the following criteria: (1) the study included patients with CTS, (2) CTS was not caused by an acute trauma or any systemic disease (such as osteoarthritis, rheumatoid arthritis, diabetes mellitus, or other connective tissue disease) as described in the definition of Complaints of the Arm, Neck and or Shoulder (CANS), (3) an intervention for treating the disorder was evaluated, and (4) results on pain, function, or recovery were reported. There were no language restrictions. If a subset of the total patients included in a study met our inclusion criteria, the study was included only if the outcomes of the subset were assessed and reported independently. Studies on the effectiveness of analgesics given presurgery, during surgery, or directly postsurgery and in which the effect of these analgesics on pain as a result of the surgery was studied are excluded from this review. Arch Phys Med Rehabil Vol 91, July 2010

Yes / No / Unsure Yes / No / Unsure Yes / No / Unsure Yes / No / Unsure Yes / No / Unsure Yes / No / Unsure Yes Yes Yes Yes

/ / / /

No No No No

/ / / /

Unsure Unsure Unsure Unsure

Study Selection Two reviewers (S.G./M.S.R. and B.M.H.) independently applied the inclusion criteria to select potential relevant studies from the title and abstracts of the references retrieved by the literature search. A consensus method was used to solve any disagreements concerning inclusion of studies, and a third reviewer (B.W.K.) was consulted if disagreement persisted. RCTs published after the search data mentioned in the (Cochrane) review and RCTs investigating interventions not summarized in a (Cochrane) review were included in this study. Categorization of the Relevant Literature Relevant articles are categorized under 3 headers: Systematic reviews, Recent RCTs, and Additional RCTs. The header “Systematic reviews” describes all Cochrane and Cochrane-based systematic reviews. The header “Recent RCTs” covers all RCTs published from the final date of the search strategy that the systematic review covered. Finally, the header “Additional RCTs” describes all RCTs concerning interventions that have not yet been described in a systematic review. Data Extraction Two authors (S.G./M.S.R. and B.M.H.) independently extracted the data. Information was collected on the study population, interventions used, outcome measures, and outcome. A consensus procedure was used to solve any disagreement between the authors. The follow-up time was categorized into short-term (0 – 3mo), midterm (4 – 6mo), and long-term (⬎6mo). Methodologic Quality Assessment To identify potential risks of bias of the included RCTs, 2 reviewers (B.M.H., M.S.R.) independently assessed the methodologic quality of each RCT. The 12 quality criteria (table 1) and operationalization of these criteria (appendix 1) were adapted from Furlan et al.14 Each item was scored as “yes,” “no,” or “don’t know.” High quality was defined as a score of 50% or more (ie, a “yes” score on 50% or more of the criteria) on the methodologic quality assessment. A consensus procedure was used to solve any disagreement between the reviewers.

EFFECTIVENESS OF SURGICAL TREATMENTS FOR CARPAL TUNNEL SYNDROME, Huisstede

Data Synthesis If a quantitative analysis of the studies was not possible because of diverse outcome measures and other clinical heterogeneity, a meta-analysis was not performed. Instead, the results were summarized using a rating system that consists of 5 levels of scientific evidence, taking into account the methodologic quality and the outcome of the original studies (bestevidence synthesis).15 The number of RCTs found in the reviews summarized together with the recent RCTs or the number of additional RCTs determined the number of RCTs for a certain intervention. The article was included in the best-evidence synthesis only if a comparison was made between the groups (treatment vs placebo, treatment vs control, or treatment vs treatment) and the level of significance was reported. The results of the study were labeled “significant” if 1 of the 3 outcome measures reported significant results. The level of evidence was ranked and divided in the following levels: 1. Strong evidence for effectiveness: consistent (ⱖ75% of the trials report the same findings) positive (significant) findings within multiple higher quality RCTs. 2. Moderate evidence for effectiveness: consistent positive (significant) findings within multiple lower quality RCTs and/or 1 high-quality RCT. 3. Limited evidence for effectiveness: positive (significant) findings within 1 low-quality RCT. 4. Conflicting evidence for effectiveness: provided by conflicting (significant) findings in the RCTs (⬍75% of the studies report consistent findings). 5. No evidence found for effectiveness of the inventions: RCTs available, but no (significant) differences between intervention and control groups were reported. 6. No systematic review or RCT found. RESULTS Characteristics of the Included Studies The initial literature search resulted in the identification of 4 systematic reviews from the Cochrane library and 47 reviews (7 from PubMed, 29 from EMBASE, 11 from CINAHL). Further, we found 750 RCTs (241 from PubMed, 276 from EMBASE, 177 from CINAHL, 56 from PEDro). Finally, after selection based on the content of the titles, abstracts, and full text of the references, 2 Cochrane reviews and 25 RCTs (22 from PubMed, 2 from EMBASE, 1 from PEDro, none from CINAHL) met our inclusion criteria. One RCT from Peck16 was initially included based on the content of the abstract. However, because the full text was not available in national and international medical libraries, we contacted the authors by e-mail. No full text of this article was received, so this particular article had to be excluded. The characteristics of the included studies are reported in appendix 2 (systematic reviews), appendix 3 (recent RCTs), and appendix 4 (additional RCTs). Methodologic Quality of the Included Studies The results of the methodologic quality assessment of the 25 included recent and additional RCTs are presented in table 2. The Cochrane review of Verdugo et al17 regarding surgical versus nonsurgical treatment applied the methodologic quality criteria of Schulz et al.18 Five items of quality were described, but no definition of high-quality or low-quality studies was given. We defined a score of 50% or more as high quality (table 3). The 9 quality items described in the methodologic quality score of van Tulder et al19 are used in the Cochrane review of

1007

Scholten et al20 reporting on surgical treatment. Because no definition of high quality is described, a score of 50% or more is defined as a high-quality RCT (table 4). In total, 62 RCTs are identified in our systematic review. Of these 62 RCTs, 35 (56%) were of high quality; 8% of the studies scored 40% to 50% of the total score. Effectiveness of Interventions Strong and moderate evidence for the effectiveness of surgical interventions for the treatment of CTS is presented in table 5. A complete overview of all levels of evidence for the effectiveness of surgical interventions is given in table 6. 1. Surgical Versus Nonsurgical Treatment Systematic review. One Cochrane review17 examined surgical versus nonsurgical treatment. A total of 4 RCTs (n⫽349) were included. One low-quality RCT21 and 1 high-quality RCT22 compared surgical treatment with splinting (a splint for 1mo and a night splint for at least 6wk, respectively). At 3 and 6 months of follow-up, in the high-quality RCT,22 significantly better results were reported on clinical improvement in favor of surgery compared with splinting (RR⫽1.38, 95% CI, 1.08 – 1.75, and RR⫽1.29, 95% CI, 1.08 –1.55, respectively). At 1 year of follow-up, the pooled estimate with regard to clinical improvement showed that surgical treatment of CTS relieves symptoms significantly better than splinting (RR⫽1.27; 95% CI, 1.05–1.53). The other 2 high-quality RCTs23,24 included in this review compared surgery with steroid injection. Ly-Pen et al23 found significantly better results in favor of corticosteroid injections compared with surgical decompression on improvement in clinical symptoms at 3 months of follow-up (RR⫽.66; 95% CI, .49 –.90). However, at 6 and 12 months of follow-up, no significant results were found between the treatment groups on the same outcome measurements. Hui et al24 reported significantly better results in favor of surgery on the outcome improvement in clinical symptoms (RR⫽2.18; 95% CI, 1.39 – 3.42) at 3 months of follow-up. Clinical improvement in grip strength was not significant at 20 weeks of follow-up. Recent RCTs. The high-quality study of Jarvik et al25 compared surgical treatment including open or endoscopic carpal tunnel decompression with nonsurgical therapy. The nonsurgical therapy included nonsteroidal anti-inflammatory drugs (ibuprofen 200mg 3 times daily), hand therapy for 6 weeks in 6 sessions, and ultrasound therapy at 6 weeks of follow-up if there was no improvement after hand therapy. Significant differences between the groups were found on the Carpal Tunnel Syndrome Assessment Questionnaire on function (MD⫽.46; 95% CI, .20 –.72) and symptoms (MD⫽.42; 95% CI, .07–.77) at 6 months of follow-up. Significant results were also found at 12 months of follow-up (function: MD⫽.40, 95% CI, .11–.70; symptoms: MD⫽.34, 95% CI, .02–.65). No significant differences were found on pain intensity at 6 months and 1 year of follow-up. Additional RCTs. The low-quality study of Ucan et al26 compared 3 intervention groups. The first group was treated with a neutral splint that should be worn 24 hours a day for 3 months. The second group also received the splint but was first injected with a local steroid. The third group was treated surgically with an open carpal tunnel release. At 6 months of follow-up, significant results on the symptom severity score were found in favor of the third group. Changes from baseline to 6 months of follow-up were as follows: group 1, mean ⫾ SD, from 2.66⫾.35 to 1.54⫾.31, versus group 2, from 2.79⫾.63 to 1.96⫾.63, versus group 3, from 3.09⫾0.5 to Arch Phys Med Rehabil Vol 91, July 2010

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Reference 55

Padua et al Jarvik et al25 Atroshi et al43 Bury73 Pomerance and Fine79 Provinciali et al78 Stevinson et al80 Kharwadkar69 Siegmeth and HopkinsonWoolley52 Jeffrey and Belcher81 Forward et al53 Chaise et al83 Hochberg82 Ucan et al26 Hamed et al68 Cook et al72 Huemer et al76 Cresswell et al67 Erel et al71 Cebesoy et al77 Finsen et al74 Martins et al75 Menovsky et al70 Stepic et al54 Tian 44

Adequate Allocation Blinding? Randomization? ConCealment? Patients?

Blinding? Caregiver?

Blinding? Outcome Assessors?

Incomplete Outcome Data Addressed? Drop-outs?

Incomplete Outcome Data? ITT Analysis?

Free of CoSuggestions interventions Similarity of of Selective Avoided or Baseline Outcome Similar? Reporting? Characteristics?

Compliance Acceptable in All Groups?

Timing of the Outcome Assessment Similar?

Maximum Score

Study Score

Percentage

⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫹ ⫹

⫹ ⫺ ⫺ ⫺

⫺ ⫺ ⫺ ⫺

⫹ ⫹ ? ⫹

⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫹ ?

⫹ ⫹ ⫹ ⫹

? ⫹ ⫹ ?

? ⫺ ? ?

NA ⫺ NA ⫹

⫹ ⫹ ⫹ ⫹

11 12 11 12

8 8 7 7

73 67 64 58

⫹ ⫹ ⫹ ⫹

⫹ ? ⫹ ?

⫺ ⫺ ⫹ ⫺

⫺ ⫺ ⫹ ⫺

⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫺ ⫹

⫹ ⫹ ⫹ ⫹

? ⫹ ⫺ ?

? ? ? ?

? ? ⫺ NA

⫹ ⫹ ⫺ ⫹

12 12 12 11

7 7 7 6

58 58 58 55

⫹

?

⫹

⫺

?

⫹

⫹

⫹

?

?

NA

⫹

11

6

55

? ⫹ ? ⫹ ⫹ ⫹ ? ⫺ ⫹ ? ⫺ ⫺ ? ? ? ?

⫹ ⫹ ? ? ? ⫹ ? ? ? ? ? ? ? ? ? ?

⫹ ⫹ ⫹ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ? ⫺

⫹ ⫺ ⫹ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺ ⫺

⫹ ⫺ ? ⫺ ? ? ? ? ? ? ? ⫺ ⫹ ? ? ?

? ⫹ ⫹ ⫹ ⫹ ? ⫹ ⫹ ⫺ ⫹ ⫹ ⫹ ? ? ? ?

? ⫺ ? ⫺ ⫺ ? ⫹ ⫹ ? ? ⫺ ? ? ? ? ?

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫺

? ? ? ⫺ ⫹ ? ? ? ? ? ? ? ? ? ? ?

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

? NA ? ⫹ ? NA ? ? NA NA ? ? ? NA NA NA

⫹ ⫺ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫺

12 11 12 12 12 11 12 12 11 11 12 12 12 11 11 11

6 5 5 5 5 4 4 4 3 3 3 3 3 2 2 0

50 45 42 42 42 36 33 33 27 27 25 25 25 18 18 0

Abbreviations; ⫹, yes: ⫺, no; ?, unsure; ITT, intention to treat; NA, not applicable (in a nontime intervention, such as surgery, compliance is not an issue).



Table 2: Methodologic Quality Scores of the Included RCTs

Table 3: Methodologic Quality Scores of the Cochrane Review of Scholten et al20

62

Intention to Treat Analysis?

Maximum Score

Study Score

Percentage

Randomization?

Similar at Baseline?

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ? ⫹ ? ⫹ ⫹ ⫹ ?

⫹ ⫹ ⫹ ? ? ⫹ ⫺ ⫹ ? ? ? ⫺ ⫹ ? ? ? ? ? ? ? ?

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫺ ? ? ⫹ ⫹ ⫺ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ? ⫹ ⫹

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ? ⫹ ⫹ ⫹ ⫹ ⫹ ⫺ ⫹ ⫹ ? ? ⫹ ? ⫹

⫹ NA NA ? ⫹ NA NA NA NA NA NA ⫹ NA NA NA NA NA NA NA NA NA

⫹ ⫹ ⫺ ⫹ ⫹ ? ⫹ ⫹ ⫹ ? ⫹ ⫹ ⫺ ? ⫺ ? ? ? ? ⫺ ?

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ? ⫹ ⫹ ⫹ ⫹ ? ? ⫹ ⫹

⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫹ ⫹ ⫺ ⫺ ⫹ ⫹ ⫹ ⫹ ? ⫺ ⫺ ⫹ ⫹ ? ⫹ ⫹ ⫹ ⫺ ⫺

9 8 8 9 9 8 8 8 8 8 8 9 8 8 8 8 8 8 8 8 8

9 8 7 7 7 6 6 6 6 6 6 6 5 5 5 5 4 4 4 4 4

100 100 88 78 78 75 75 75 75 75 75 67 63 63 63 63 50 50 50 50 50

?

?

?

⫹

NA

?

⫹

⫹

⫹

8

4

50

? ⫹ ? ? ? ? ⫺ ? ? ⫹ ?

? ⫺ ? ? ? ? ? ? ? ? ?

? ? ⫹ ⫹ ⫹ ? ? ? ? ? ?

⫹ ⫹ ? ⫹ ? ⫹ ? ? ? ? ?

? NA NA NA NA NA NA NA NA ? NA

? ? ⫹ ? ? ? ? ? ? ? ?

⫹ ⫺ ? ? ? ? ? ? ⫹ ? ?

⫹ ⫹ ⫹ ⫺ ⫹ ⫹ ⫹ ⫹ ? ? ?

⫹ ⫺ ? ? ? ⫺ ? ? ? ? ⫺

9 8 8 8 8 8 8 8 8 9 8

4 3 3 2 2 2 1 1 1 1 0

44 38 38 25 25 25 13 13 13 11 0

Blinding Patient?

Abbreviations: ⫹, yes; ⫺, no, ?, unsure; ⫾, in part; NA, not attempted.

1009


Dias et al Saw et al33 Atroshi et al27 Leinberry et al65 Mackinnon et al64 Benedetti28 and Sennwald 34 Brown et al29 Jugovac et al58 Nakamichi and Tachibana59 Rab et al46 Trumble et al36 Lowry and Follender63 Bhattacharya et al48 Brüser56 and Richter61 Jacobsen and Rahme32 Wong et al47 Citron and Bendall57 Erdmann39 Ferdinand and MacLean30 Helm and Vaziri49 Hoefnagels et al31 Stark and EngkvistLofmark35 Holmgren-Larsson86 and Holmgren87 Dumontier et al37 Macdermid et al41 Cellocco et al50 Westphal et al42 Mackenzie et al45 Agee et al10 Foucher et al40 Nitzsche and Steen60 Shum et al66 Eichhorn and Dieterich38

Assessment Timing Similar?

Allocation Concealment?


Reference

Blinding Outcome Assessors?

Dropout Rate Described and Acceptable?

Cointerventions Avoided or Similar?

1010

EFFECTIVENESS OF SURGICAL TREATMENTS FOR CARPAL TUNNEL SYNDROME, Huisstede Table 4: Methodologic Quality Scores of the Cochrane Review of Verdugo et al17 Reference 23

Ly-Pen et al Gerritsen et al22 Hui et al24 Garland et al21

Randomization?

Allocation Concealment?

Baseline Differences?

Patient Blinded?

Observer Blinded?

Maximum Score

Study Score

Percentage

⫹ ⫹ ⫹ ⫹

⫹ ⫹ ⫹ ?

⫹ ⫹ ⫹ NR

NA NA NA NA

NA ⫺ ⫺ NA

3 4 4 3

3 3 3 1

100 75 75 33

Abbreviations: ⫹, yes; ⫺, no; ?, unsure; ⫾, in part; NA, not attempted; NR, not reported.

1.41⫾.31 (P⫽.004). Also at 6 months of follow-up, significant results in favor of the third group were found on the function capacity scale. Changes from baseline to 6 months of follow-up were as follows: group 1, mean ⫾ SD, from 2.47⫾.65 to 1.75⫾.26, versus group 2, from 2.19⫾.51 to 1.69⫾.31, versus group 3, from 2.7⫾.62 to 1.52⫾.34 (P⫽.03). At 3 months of follow-up, no significant changes were found. In conclusion, there is moderate evidence that surgical treatment is more effective than splinting in the midterm and long term, and there is conflicting evidence for the short term. There is conflicting evidence for the short term (3mo) and no evidence for the effectiveness of surgery compared with corticosteroid injections in the midterm and long term. Furthermore, there is moderate evidence that surgical treatment is more effective than nonsurgical therapy using nonsteroidal anti-inflammatory drugs plus hand therapy (plus ultrasound in cases not responding to hand therapy) in the midterm and long term. 2. Surgery: Various Surgical Techniques One Cochrane review by Scholten,20 6 recent RCTs, and 1 additional RCT were found that dealt with various surgical techniques. The Cochrane review by Scholten20 reported on studies comparing various surgical techniques for the treatment of CTS and included 33 studies (n⫽2021). Endoscopic Carpal Tunnel Release Versus Open Carpal Tunnel Release Systematic review. In total, 10 high-quality studies27-36 and 7 low-quality studies11,37-42 reported on endoscopic versus

Table 5: Strong and Moderate Evidence for Effectiveness of Surgical Interventions for CTS Surgery to treat CTS Pre-operative Various surgical techniques Post-surgical Surgery vs non-surgical Sutures 公

0 公a

0


Endoscopic Carpal Tunnel Release Versus Open Release With a Modified Incision Systematic review. In the 4 studies38,45-47 reporting on endoscopic carpal tunnel release versus open release with a modified incision, no significant differences were found for short-term or long-term outcomes of pain, function, and recovery, except 1 study47 that found significant results at 2 and 4 weeks of follow-up, but not at 8 and 16 weeks and 6 and 12 months of follow-up (no exact data given). Therefore, there is no evidence for the effectiveness of endoscopic carpal tunnel release compared with open release with a modified incision in the short term, midterm, and long term.

公b,c,d,e

0

Strong or moderate evidence found; 0: RCTs found, but only limited, conflicting, or no evidence for effectiveness of interventions was found. Short-term: a Moderate evidence: corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release. Midterm: b Moderate evidence: surgical treatment* vs splinting. d Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy. Long-term: c Moderate evidence: surgical treatment* vs splinting. e Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy. *in favor of.

open carpal tunnel release. Two27,36 of 10 studies reported results for the short term (ⱕ3mo) and found significant results for at least 1 of the outcome measures; 127 of 8 studies that reported results for the long term (⬎3mo) found significant differences in favor of the endoscopic approach after 12 months (MD⫽–5.8; 95% CI, –13.3 to –1.7). Pooling of the data was possible with only 3 studies27,31,36 (symptom severity score, short-term, WMD⫽–.17, 95% CI, –.53 to .20; long-term, WMD⫽.00, 95% CI, –.17 to .17; functional status score, shortterm, WMD⫽–.22, 95% CI, –.60 to .16; long-term, WMD⫽.08, 95% CI, –.06 to .22). Recent RCTs. Atroshi et al43 (n⫽128) reported on the 5-year follow-up results of the study population as described in the high-quality study of Atroshi et al27 in the Cochrane review of Scholten.20 No significant differences were found between open and endoscopic carpal tunnel release on the symptom severity scale and the function severity scale at 5-year followup. Additionally, the low-quality study of Tian et al44 (n⫽62) compared open with endoscopic carpal tunnel release and found no significant differences on symptom improvement at 2-year follow-up. In conclusion, we found no evidence for the effectiveness of endoscopic compared with open carpal tunnel release in the short term and long term.

Mini-Open Technique Assisted by Knifelight Instrument Versus Standard Open Carpal Tunnel Release Systematic review. Two high-quality studies48,49 and 1 low-quality study50 compared the miniopen technique assisted by the Knifelight instrument versus standard open release or open release with mini-incision (ⱕ3mo: OR⫽.76; 95% CI, .14 – 4.28). Of these, only 1 low-quality study50 found a significant result in favor of the Knifelight instrument on the symptom severity score after a mean follow-up of 19 months (range, 12–28mo). However, these results were not maintained at a mean follow-up of 30 (range, 24 – 42) or 6051 months. So, there is limited evidence that the miniopen technique assisted by the Knifelight instrument is more effective than a standard open release at a follow-up of 19 months; however,

Table 6: Complete Overview of Evidence for Effectiveness of Surgical Interventions for CTS Surgical Treatment Various Surgical Techniques

Postoperative

Surgical vs Nonsurgical

Sutures

–Endoscopic vs open carpal tunnel release Short-term: NE Long-term: NE –Endoscopic vs open carpal tunnel release with modified incision Short-term: NE Midterm: NE Long-term: NE –Miniopen technique assisted by Knifelight instrument* vs standard open release Short-term: NE 19mo: ⫹ 30 and 60mo: NE –Open release with modified vs standard incision Short-term: NE Long-term: NE –With vs without lengthening of the flexor retinaculum in open carpal tunnel release Short-term: NE Midterm: NE –With vs without internal neurolysis in open carpal tunnel release Short-term: NE Long-term: NE –With vs without epineurotomy in open carpal tunnel release Long-term: NE –With vs without tenosynovectomy in open carpal tunnel release Long-term: NE –Nerve-preserving decompression vs standard decompression of the carpal tunnel Short-term: NE Midterm: NE –Open carpal tunnel release with vs without preservation of the ulnar bursa Short-term: NE –Miniopen technique using the Biomet TM Indiana Tome vs standard open limited incision Short-term: NE Long-term: NE –Double* vs standard Single incision technique Short-term: ⫹ Midterm: ⫹ –Open carpal tunnel release with perineural steroid injection immediately after decompression vs no perineural steroid injection after decompression Short-term: NC –Corticosteroid irrigation* of the median nerve before skin closure as additive to carpal tunnel release Short-term: ⫹⫹

–Splinting vs no splinting Short-term: NE Midterm: NE –Splinting with physical exercises vs no splint with immediate physical exercises Short-term: NE –Arnica vs placebo Short-term: ⫾ –Naftidrofuryl* vs placebo Short-term: ⫹ –Controlled cold therapy vs conventional ice therapy Short-term: NE –Supervised exercises vs home exercise program program Short-term: NE Midterm: NE

–Surgical treatment* vs splinting Short-term: ⫾ Midterm: ⫹⫹ Long-term: ⫹⫹ –Surgical treatment vs corticosteroid injections Short-term: ⫾ Midterm: NE Long-term: NE –Surgical treatment* vs anti-inflammatory drugs plus hand therapy (plus ultrasound in cases not responding to hand therapy) Midterm: ⫹⫹ Long-term: ⫹⫹

–Vicryl sutures vs prolene sutures Short-term: ⫾ –Vicryl vs nylon or stainless sutures Short-term: NE

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Abbreviations: X, no systematic review or RCT found; ⫹, limited evidence found; ⫹⫹, moderate evidence found; ⫹⫹⫹, strong evidence found; ⫾, conflicting evidence for effectiveness; NC: RCT was found, but no comparison was made between the intervention and control groups, thus no evidence was found; NE: no evidence found for effectiveness of the treatment: RCTs available, but no differences were found between intervention and control groups. *In favor of.



Preoperative

–Pre-operative splinting vs no splinting* Short-term: ⫹ Midterm: NE

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there is no evidence in the short and the long term (30 and 60mo). Carpal Tunnel Decompression With Preserving Technique Versus Standard Technique Recent RCTs. The high-quality RCT52 (n⫽84) found no significant differences in favor of carpal tunnel decompression by using a technique with a goal to preserve the superficial nerve branches compared with a standard technique on scar pain scores or the second part of the Patient Evaluation Measure score at 3 months and at 6 months of follow-up. The low-quality RCT of Forward et al53 (n⫽111) compared open carpal tunnel release with preservation of the parietal layer of the ulnar bursa to division of the ulnar bursa. No significant differences were found on grip strength and the Patient Evaluation Measure score at 9 weeks of follow-up. In conclusion, no evidence was found in favor of nervepreserving decompression compared with standard decompression of the carpal tunnel in the short term and midterm. Furthermore, we found no evidence for open carpal tunnel release with preservation of the parietal layer of the ulnar bursa compared with division of the ulnar bursa in the short term. Steroids as Additive to Open Carpal Tunnel Release Recent RCTs. The low-quality study of Stepic et al54 examined a perineural injection of 1mL betamethasone as additive to open carpal tunnel release. At 7 days of follow-up, 77.5% of those treated with surgery and the betamethasone injection had reduction of symptoms. This group demonstrated a reduction of symptoms of 97.5% at 90 days of follow-up. In those treated only with surgery, symptoms had disappeared in 75% at 7 days of follow-up and in 95% at 90 days of follow-up. No comparisons between the groups were made. Additional RCTs. Padua et al55 studied corticosteroid irrigation of the median nerve before skin closure as additive to release of the transverse carpal ligament. Significant differences were found on the symptom severity score in favor of those with corticosteroid irrigation in the short term (corticosteroid irrigation group, mean ⫾ SD [95% CI], from 44.8⫾6.0 [41.0 – 48.6] at baseline to 11.8⫾1.3 [10.8 –12.7] at 60 days, compared with the release-only group, from 41.8⫾5.4 [37.6 – 45.9] at baseline to 19.4⫾2.1 [17.8 –21.1] at 60 days; P⫽.005), but no significant differences on the function severity score in the short term at 60 days. Therefore, there is no evidence for the effectiveness of a perineural steroid injection with 1mL betamethasone as additive to open carpal tunnel release. Furthermore, there is moderate evidence that corticosteroid irrigation of the median nerve before skin closure as additive to surgical release of the carpal ligament is effective in the short term. Other Surgical Techniques Systematic review. Four high-quality56-59 and 2 low-quality RCTs38,60 included in the Cochrane review of Scholten20 reported on open tunnel release with a modified versus standard incision (4 RCTs56,58,59,61 short-term, 2 RCTs38,57 long-term; ⱕ3mo, RR⫽1.00; 95% CI, .83–1.20), with or without lengthening of the flexor retinaculum (1 high-quality study62 reporting on short-term and midterm results), with or without internal neurolysis (1 high-quality study63 reporting on short-term and 1 high-quality study64 reporting on long-term results; overall improvement ⱕ3mo, RR⫽1.02; 95% CI, .68 –1.54, and ⬎3mo, RR⫽.92; 95% CI, .74 –1.14), with or without epineurotomy (overall improvement after 3mo, RR⫽.93; 95% CI, .58 –1.50; 1 high-quality study,65 long-term), and with or without tenoArch Phys Med Rehabil Vol 91, July 2010

synovectomy (1 low-quality study,66 long-term) and found no significant differences in favor of one of the interventions studied. Recent RCTs. The low-quality RCT of Cresswell et al67 (n⫽200) studied carpal tunnel decompression using the Biomet TM Indiana Tome (miniopen technique) compared with standard limited palmar open incision and found significant effects on the Levine-Katz questionnaire on symptoms at 7 years of follow-up (TM Indiana Tome, mean, 16.0, vs open incision, 13; P⬍.05). No significant differences were found on the Levine-Katz questionnaire on symptoms 3 months after surgery; the Levine-Katz questionnaire on function 3 months and 7 years after surgery; and pain, grip strength, and pinch grip 3 months after surgery. The low-quality study of Hamed et al68 studied open carpal tunnel decompression comparing a doubleincision technique with the standard single-incision technique. Significant differences were found on pain in favor of the double incision technique at 3 and 6 months of follow-up (number of wrists with pillar pain, double incision, 4/19, vs single incision, 12/21, at 3mo follow-up, P⫽.04; number of wrists with pillar pain, double incision, 1/19, vs single incision, 8/21, at 6mo follow-up, P⫽.03). No benefit was found on grip strength at 3 and 6 months of follow-up. In conclusion, there is no evidence with regard to open tunnel release with a modified versus standard incision in the short term and long term, or open carpal tunnel release with compared to without lengthening of the flexor retinaculum in the short term and midterm. Moreover, there is no evidence for the effectiveness of internal neurolysis in the short term and long term, epineurotomy in the long term, tenosynovectomy in the long term, or miniopen technique using the Biomet TM Indiana Tome compared with standard open incision in the short term and long term. There is limited evidence for the miniopen technique using the Biomet TM Indiana Tome compared with standard open incision at 7 years of follow-up, and for the double compared with standard single incision technique in the short term and midterm. 3. Sutures in Surgery Additional RCTs. Three RCTs reporting on the effectiveness of the use of different kind of sutures in carpel tunnel surgery were found.69-71 One high-quality RCT69 and 1 low-quality study71 examined absorbable versus nonabsorbable sutures in carpal tunnel decompression. In the high-quality study,69 no significant differences in favor of the absorbable or nonabsorbable sutures on pain were found at 12 weeks of follow-up, although a significantly higher level of wound inflammation was found in those in whom absorbable sutures were used. In contrast, Erel et al71 found significant differences in pain levels (no exact data given; P⫽.016) in favor of the group in which nonabsorbable sutures were used at 6 weeks of follow-up. The low-quality study of Menovsky et al70 found no significant differences among the use of vicryl, nylon, and stainless sutures in skin closure on CTS symptoms at 6 weeks of follow-up. However, Menovsky70 concluded that both nylon and stainless steel sutures are suitable for skin closure, but did not recommend the use of absorbable vicryl sutures because the incidence of infections was found only in the vicryl suture group and not in the nylon and steel suture groups. Moreover, significantly more suture granulomas were present in the vicryl group (no exact data given; P⬍.05). In conclusion, there is conflicting evidence for the use of vicryl sutures compared with prolene sutures in skin closure in carpel tunnel surgery in the short term. Further, there is no


evidence in favor of the use of vicryl, nylon, or stainless sutures in the short term. However, the use of vicryl sutures seemed to produce more adverse side effects, such as infection. 4. Preoperative Treatments Additional RCTs. We found 1 low-quality additional RCT reporting on preoperative treatment. Cook et al72 (n⫽50) studied 2 weeks of splinting in a neutral position before open carpal tunnel release followed by 2 weeks of splinting versus controls (ie, a bulky dressing) before surgery followed by unrestricted active movement. One month after surgery, significant differences were found on all outcome measures in favor of no splinting (grip strength, splint, mean, 14kg, vs controls, 18kg, P⫽.02; key pinch strength, splint, 5kg, vs controls, 7kg, P⫽.01; subjective pain, splint, 1.5, vs controls, 0.5). However, no significant differences were found on all outcome measures at 6 months postsurgery. Thus, we found limited evidence that no preoperative splinting is more effective than preoperative splinting in the short term, and no evidence in favor of one of these treatments in the midterm. 5. Postoperative Treatments Immobilization Additional RCTs. Five additional RCTs studied the effectiveness of immobilization after surgery for CTS. The low-quality study of Bury et al73 (n⫽43) compared a bulky dressing and splinting in a neutral wrist position for 2 weeks with controls (ie, only a bulky dressing) after carpal tunnel release. No significant effects on grip strength were found in this RCT. At 6 months of follow-up, no significant differences were found on pain (VAS), grip strength, and key pinch strength between a plaster of Paris splint in slight dorsiflexion for 4 weeks and controls (ie, a very light dressing) after open carpal tunnel release in a low-quality RCT of Finsen et al74 (n⫽82) The low-quality RCT of Martins et al75 (n⫽52) compared splinting after open carpal tunnel release for 2 weeks with controls (no intervention). No significant differences were found on the Boston Questionnaire after 2 weeks of treatment. The low-quality RCT of Huemer et al76 (n⫽50) examined the effectiveness of splinting compared with controls (ie, a light bandage) after open carpal tunnel release for 48 hours. No significant differences were found between the splint group and control group on pain (VAS), grip strength, and the pick-up test at 3 months of follow-up. The low-quality study of Cebesoy et al77 (n⫽40) compared splinting during 10 days following standard physical exercises with controls (ie, no splinting and immediate physical exercises) after open carpal tunnel release. At 3 months of follow-up, significant differences were reported on the function (symptom) severity scale in favor of controls (splint, mean, 37.75 to 13.50, vs controls, 36.32 to 11.90; P⫽ .023). No significant difference was found on functional status scale. Therefore, we concluded that there is no evidence for the effectiveness of immobilization by splinting compared with no splint after carpal tunnel surgery in the short term and midterm, or splinting with physical exercises compared with no splint with immediate physical exercises to treat CTS in the short term. Exercise Additional RCTs. One of the 2 high-quality RCTs78 (n⫽100) compared a multimodal rehabilitation training program of 2 weeks starting 12 days after carpal tunnel surgery

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with a home exercise program for 2 weeks. Two months after surgery, no significant effects were found on the Boston Carpal Tunnel Questionnaire, Jebsen-Taylor test, and the 9-hole peg test. Pomerance and Fine79 (n⫽150) followed patients after carpal tunnel release treated by a hand therapist for 2 weeks or doing home therapy exercises without supervision. No significant differences on pain, grip, and pinch strength and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire were found after 3 and 6 months of follow-up. In conclusion, there is no evidence for the effectiveness of supervised exercise compared with a home exercise program after carpel tunnel surgery in the short term, or for a multimodal rehabilitation training program compared with a home exercise program for the treatment of CTS in the short term and midterm. Arnica Additional RCTs. Two additional high-quality RCTs80,81 assessed the use of arnica to relieve pain after surgery in patients with CTS. Stevinson et al80 (n⫽62) did not find any advantage with the use of arnica tablets over placebo in reducing postoperative pain after 2 weeks. In contrast, Jeffrey and Belcher81 (n⫽37) found a significant reduction in hand discomfort after 2 weeks in the group treated with arnica (tablets plus ointment; arnica, mean, 1.3, vs placebo, 2.5; P⬍.03). Thus, we found conflicting evidence for the effectiveness of arnica as treatment after carpel tunnel surgery in the short term. Other Postoperative Treatments Additional RCTs. The low-quality trial of Hochberg82 (n⫽72) examined 2 types of cold therapy: controlled cold therapy using a temperature-controlled cooling blanket versus conventional ice therapy using an ice pack. Three days after surgery, both treatment groups showed a significant reduction of pain, with no significant differences between them. In the low-quality study of Chaise et al83 (n⫽195), compared with placebo, the use of naftidrofuryl (a vasodilator) after carpel tunnel surgery showed a significant reduction of symptoms (P⬍.05) after 30 days. Therefore, we conclude that there is no evidence for the effectiveness of controlled cold therapy versus conventional ice therapy in the short term, and limited evidence that naftidrofuryl is more effective than placebo after carpel tunnel surgery in the short term. DISCUSSION This systematic review aimed to provide an overview of the current state-of-the-art regarding the effectiveness of surgical interventions for the management of CTS. Moderate evidence was found in favor of surgical treatment compared with splinting in the midterm and long term or compared with antiinflammatory drugs plus hand therapy in the short term and midterm, and for the effectiveness of corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release in the short term. Limited evidence was found in favor of a double versus standard single incision technique. Also, limited evidence was found in favor of a miniopen technique assisted by a Knifelight instrument compared with a standard open release at 19 months of follow-up. However, in the short term and at 30 months of follow-up, no significant differences between the latter procedures were found. Many studies compared different surgical interventions, but no evidence was found in favor of any one of them. Taking our results into consideration, surgical treatment appears to be more effective compared with prolonged conserArch Phys Med Rehabil Vol 91, July 2010

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vative treatment in the midterm and long term. However, it remains unclear whether surgical treatment is the intervention of first choice. In the literature, conservative treatment is given preference in mild to moderate cases of CTS, and surgical treatment is mainly applied in severe cases.84 Surgical treatment is also indicated in cases in which initial conservative management fails. More studies are needed to compare conservative and surgical treatment. Surgical interventions are more invasive and can result in more complications compared with conservative treatment, albeit the actual numbers are expected to be minimal. Although we found a large number of RCTs (n⫽40) examining various surgical techniques of carpal tunnel decompression, there is no unequivocal evidence showing that one surgical treatment is superior to the other in treating CTS. Also, no RCTs explored the optimal timing strategy, even though timing is an important factor for total recovery after surgery. For example, a long-lasting compression can result in axonal damage, which will not improve after surgery. Future RCTs should also explore the timing of surgery. To our knowledge, this is the first systematic review reporting on preoperative and postoperative treatment programs. We found only 1 low-quality study on preoperative intervention.72 Preoperatively, limited evidence was found in favor of no splinting compared with splinting. Five RCTs reported on postoperative splinting, but no evidence for the effectiveness of this intervention was found. Also, no evidence (or only limited evidence) was found for other postoperative interventions. According to these results, preoperative and postoperative interventions do not contribute to enhanced improvement of outcome. However, more RCTs are needed to provide additional evidence for this statement. Study Limitations Some methodologic weaknesses of this review need to be mentioned. First, because of the heterogeneity of the studies, for most comparisons, we refrained from statistical pooling of the results of the individual trials. A single-point estimate of the effect of the interventions included for a single specific hand disorder would probably not do justice to the difference between the trials regarding patient characteristics, interventions, and outcome measures. The use of a best-evidence synthesis is a next-best solution and a transparent method commonly applied in the field of musculoskeletal disorders for those instances when statistical pooling is not feasible or clinically viable.15 Second, 57% of the included RCTs had a methodologic quality score of high quality. Thus, more high-quality RCTs are needed to promote more evidence-based practice. Third, the Cochrane reviews of Scholten20 and Verdugo et 17 al used methodologic quality criteria that were different from the criteria of Furlan et al85 that we used. In our protocol, we decided to apply the definitions of high-quality and low-quality studies as used in a Cochrane review. The quality criteria of the 2 Cochrane reviews20,28 also had fewer items than our 12 quality criteria, which could be a source of bias with regard to evidence and conclusions about treatment outcome. CONCLUSIONS Taking into account the present review on surgical treatment (Part II) as well as the review on conservative treatment of CTS (Part I),7 we conclude that long-term results are lacking regarding interventions to treat CTS. Future research should focus on the long-term results of conservative interventions, and subsequently, comparisons should be made between effective conArch Phys Med Rehabil Vol 91, July 2010

servative and surgical interventions. RCTs on the surgical treatment of patients with CTS should also concentrate on the optimal timing for carpel tunnel surgery. We found moderate evidence that surgical treatment is more effective than splinting or anti-inflammatory drugs plus hand therapy in the midterm and long term to treat CTS. However, there is no unequivocal evidence that suggests one surgical treatment is more effective than the other. Further, moderate evidence was found that corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release is effective in the short term. No evidence was found for the efficacy of various presurgical or postsurgical treatment programs, including splinting. APPENDIX 1: OPERATIONALIZATION CRITERIA METHODOLOGIC QUALITY Criteria for a Judgment of “Yes” for the Sources of Risk of Bias 1. Was the method of randomization adequate? A random (unpredictable) assignment sequence. Examples of adequate methods are coin toss (for studies with 2 groups), rolling dice (for studies with 2 or more groups), drawing of balls of different colors, drawing of ballots with the study group labels from a dark bag, computer-generated random sequence, preordered sealed envelopes, sequentially ordered vials, telephone call to a central office, and preordered list of treatment assignments. Examples of inadequate methods are alternation, birth date, social insurance/security number, date in which they are invited to participate in the study, and hospital registration number. 2. Was the treatment allocation concealed? Assignment generated by an independent person not responsible for determining the eligibility of the patients. This person has no information about the persons included in the trial and has no influence on the assignment sequence or on the decision about eligibility of the patient. Was knowledge of the allocated interventions adequately prevented during the study? 3. Was the patient blinded to the intervention? This item should be scored “yes” if the index and control groups are indistinguishable for the patients or if the success of blinding was tested among the patients and it was successful. 4. Was the care provider blinded to the intervention? This item should be scored “yes” if the index and control groups are indistinguishable for the care providers or if the success of blinding was tested among the care providers and it was successful. 5. Was the outcome assessor blinded to the intervention? Adequacy of blinding should be assessed for the primary outcomes. This item should be scored “yes” if the success of blinding was tested among the outcome assessors and it was successful or: ●

●

For patient-reported outcomes in which the patient is the outcome assessor (eg, pain, disability): the blinding procedure is adequate for outcome assessors if participant blinding is scored “yes.” For outcome criteria assessed during scheduled visit and that supposes a contact between participants and outcome assessors (eg, clinical examination): the blinding proce-

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●

●

●

dure is adequate if patients are blinded and the treatment or adverse effects of the treatment cannot be noticed during clinical examination. For outcome criteria that do not suppose a contact with participants (eg, radiography, magnetic resonance imaging): the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed when assessing the main outcome. For outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (eg, co-interventions, hospitalization length, treatment failure), in which the care provider is the outcome assessor: the blinding procedure is adequate for outcome assessors if item “E” is scored “yes.” For outcome criteria that are assessed from data of the medical forms: the blinding procedure is adequate if the treatment or adverse effects of the treatment cannot be noticed on the extracted data.

Were incomplete outcome data adequately addressed? 6. Was the dropout rate 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. If the percentage of withdrawals and dropouts does not exceed 20% for short-term follow-up and 30% for longterm follow-up and does not lead to substantial bias, a “yes” is scored. (N.B. these percentages are arbitrary, not supported by literature). 7. Were all randomized participants analyzed in the group to which they were allocated? All randomized patients are reported/analyzed in the group they were allocated to by randomization for the most important moments of effect measurement (minus missing values) irrespective of noncompliance and co-interventions.

8. Are reports of the study free of suggestion of selective outcome reporting? In order to receive a “yes,” the review author determines if all the results from all prespecified 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. Other sources of potential bias 9. Were the groups similar at baseline regarding the most important prognostic indicators? In order to receive a “yes,” groups have to be similar at baseline regarding demographic factors, duration and severity of complaints, percentage of patients with neurological symptoms, and value of main outcome measures. 10. Were co-interventions avoided or similar? This item should be scored “yes” if there were no cointerventions or they were similar between the index and control groups. 11. Was the compliance acceptable in all groups? The reviewer determines whether the compliance with the interventions is acceptable, based on the reported intensity, duration, number, and frequency of sessions for both the index intervention and control interventions. For example, physiotherapy treatment is usually administered over several sessions; therefore, it is necessary to assess how many sessions each patient attended. For single-session interventions (for example, surgery), this item is irrelevant. 12. Was the timing of the outcome assessment similar in all groups? Timing of outcome assessment should be identical for all intervention groups and for all important outcome assessments.

APPENDIX 2: SYSTEMATIC REVIEWS: CTS Author

Verdugo et al17 (4 RCTs)

No. of Patients

Treatment

349

Surgical versus nonsurgical Surgery

Surgery

Placebo

Control/Comparison

Outcome Measures

Splinting

Clinical improvement

Steroid injection

Clinical improvement

Effect Size

3mo: RR⫽1.38 (95% CI, 1.08 to 1.75) (1 RCT) in favor of surgery 6mo: RR⫽1.29 (95% CI, 1.08 to 1.55) (1 RCT) in favor of surgery 1 year: RR⫽1.27 (95% CI, 1.05 to 1.53) (2 RCTs) in favor of surgery 3mo: RR⫽.66 (95% CI, .49 to .90) in favor of steroid injection 3mo: RR⫽2.18 (95% CI, 1.39 to 3.42) (2 RCTs) in favor of steroid injection 6mo: RR⫽.95 (95% CI, .71 to 1.29) (1 RCT) 1y: not significant (no RR given)


1016


APPENDIX 2: SYSTEMATIC REVIEWS: CTS (Cont’d) No. of Patients

Author

Treatment

Placebo

Control/Comparison

Outcome Measures

Grip strength

Scholten et al20 (33 RCTs)

2021

Various surgical techniques Endoscopic release

Open: modified incision Open: with Knifelight instrument Open: with internal neurolysis

Open: with epineurotomy Open: with tenosynovectomy

Effect Size

20wk: RR⫽.71 (95% CI, .43 to 1.15)

Open carpal tunnel Overall improvement RR⫽1.01 (95% CI, .97 to release 1.05) Symptom severity score ⱕ3mo: WMD⫽⫺.17 (Levine) (95% CI, ⫺.53 to .20) ⬎3mo: WMD⫽.00 (95% CI, ⫺.17 to .17) Functional status score ⱕ3mo: WMD⫽⫺.22 (Levine) (95% CI, ⫺.60 to .16) ⬎3mo: WMD⫽.08 (95% CI, ⫺.06 to .22) Pain 12mo: MD⫽⫺5.8 (95% CI, ⫺13.3 to -1.7) In favor of endoscopic release Open: standard Overall improvement ⱕ3mo: RR⫽1.00 (95% incision CI, .83 to 1.20) Overall improvement ⱕ3mo: OR⫽.76 (95% CI, Open: without .14 to 4.28) Knifelight instrument Overall improvement ⱕ3mo: RR⫽1.02 (95% Open: without CI, .68 to 1.54) internal ⬎3mo: RR⫽.92 (95% CI, neurolysis .74 to 1.14) Open: without Overall improvement After 3mo: RR⫽.93 epineurotomy (95% CI, .58 to 1.50) Open: without Symptom severity score After 3mo: WMD⫽.00 tenosynovectomy (Levine) (95% CI, .29 to .29) Functional status score After 3mo: WMD⫽.10 (Levine) (95% CI, ⫺.18 to .38)

APPENDIX 3: RECENT RCTs: CTS Author Jarvik et al25

Treatment

Placebo

Surgical vs nonsurgical Surgery: open or endoscopic decompression of the carpal tunnel (n⫽57)

Control/Comparison

Nonsurgical therapy: Nonsteroidal antiinflammatory drugs (ibuprofen 3 times daily 200mg) ⫹ hand therapy 6 sessions in 6wk ⫹ Splinting; ultrasound was offered in patient who did not improve at 6wk follow-up (n⫽59)

Outcome Measures (Total Follow-Up Time)

Pain intensity (12mo)

Results—Statistical

NS, no P value given P⫽0.0993

P⫽0.1590

Carpal Tunnel Syndrome Assessment Questionnaire Function score (12mo)



Results by Outcome Measure Surgical: mean ⫾ SD, 6.6⫾2.6, vs nonsurgical, 6.8⫾2.5 at baseline Surgical: mean ⫾ SD, 4.7⫾3.2, vs nonsurgical, 5.7⫾3.1 at 6mo follow-up Treatment effect (difference between groups): MD⫽1.0 (95% CI, ⫺0.2 to 2.1) Surgical: mean ⫾ SD, 3.5⫾3.0, vs nonsurgical, 4.3⫾3.3 at 12mo follow-up Treatment effect (difference between groups): MD⫽.90 (95% CI, ⫺0.3 to 2.1)

Surgical: mean ⫾ SD, 2.42⫾.82, vs nonsurgical, 2.53⫾.82 at baseline Surgical: mean ⫾ SD, 1.91⫾.88, vs nonsurgical, 2.44⫾.87 at 6mo follow-up Treatment effect (difference between groups): MD⫽.46 (95% CI, .20 to .72)


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APPENDIX 3: RECENT RCTs: CTS (Cont’d) Author

Treatment

Placebo

Control/Comparison


Results—Statistical P⫽0.0081

Symptom score (12mo)


P⫽0.0357

Atroshi et al43

Cellocco et al51†

Tian et al44

Siegmeth et al52

Various surgical techniques Endoscopic carpal tunnel release (n⫽62)

Mini incision carpal tunnel release using a Knifelight instrument (n⫽99)

Open carpal tunnel release (n⫽65)

Standard limited open carpal tunnel release technique (n⫽123)

One-portal endoscopic carpal tunnel release (n⫽32, 34 hands) Nerve-preserving

Open carpal tunnel release (n⫽30, 36 hands) Standard

CTD (n⫽42)

CTD (n⫽42)

Symptom severity scale (5y)

P⫽0.82

Function severity scale (5y)

P⫽0.78

Boston Carpal Tunnel Questionnaire Symptoms (60mo)

P⫽0.629

Function (60mo)

P⫽0.678

Symptom relief (2y)

P⬎0.05

Scar pain scores

P⫽0.59

P⫽0.38

PEM score, second part (ie, outcome, range 1–7)

P⫽0.43

P⫽0.13

Forward et al53

Open carpal tunnel release with preservation of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n⫽53)

Open carpal tunnel release with division of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n⫽58)

Grip strength (9wk)

P⫽0.661

Patient Evaluation Measure score (9wk)

P⫽0.990

Results by Outcome Measure Surgical: mean ⫾ SD, 1.74⫾.79, vs nonsurgical, 2.17⫾.96 at 12mo follow-up Treatment effect (difference between groups): MD⫽.40 (95% CI, .11 to .70) Surgical: mean ⫾ SD, 2.95⫾.77, vs nonsurgical, 3.01⫾.64 at baseline Surgical: mean ⫾ SD, 2.02⫾1.03, vs nonsurgical, 2.42⫾.80 at 6mo follow-up Treatment effect (difference between groups): MD⫽.42 (95% CI, .07 to .77) Surgical: mean ⫾ SD, 1.74⫾.76, vs nonsurgical 2.07⫾.88 at 12mo follow-up Treatment effect (difference between groups): MD⫽.34 (95% CI, .02 to .65)

Difference in means (95% CI) from baseline to 5y: .03 (⫺.21 to .27) Difference in means (95% CI) from baseline to 5y: .02 (⫺.17 to .23)

Knifelight: mean ⫾ SD, 1.33⫾.64, vs standard: 1.38⫾.83 at 60mo follow-up Knifelight: mean ⫾ SD, 1.80⫾0.78, vs standard: 1.75⫾.97 at 60mo follow-up Rate of excellent to good: endoscopic (93.2%) vs open 91.5% 3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) Preservation of ulnar bursa: mean ⫾ SD, 4.1⫾.32 at baseline to mean (95% CI), 13.2 (10.7 to 15.7) at 9wk follow-up vs division of ulnar bursa: 20.0⫾1.7 at baseline to 14.7 (11.3 to 18.2) at 9wk follow-up Preservation of ulnar bursa: mean ⫾ SD, 54⫾0.3 at baseline to mean (95% CI), 26 (21 to 32) at 9wk follow-up vs division of ulnar bursa: 57⫾0.3 at baseline to 25 (20 to 30) at 9wk follow-up


1018


APPENDIX 3: RECENT RCTs: CTS (Cont’d) Author

Treatment

Stepic et al54

Decompression of the median nerve by open carpal tunnel release with perineural injection of 1mL betamethasone immediately after decompression (n⫽20) Carpal tunnel decompression using the Biomet TM Indiana Tome (miniopen technique; n⫽100)

Cresswell et al67

Placebo

Control/Comparison



Disappearance of symptoms (%; 90d)

No P value given

Treatment group: 77.5% 7d after treatment and 97.5% 90d after treatment vs controls: 75% 7d after treatment and 95% 90d after treatment‡

Carpal tunnel decompression using the standard limited palmar open incision (n⫽100)

Pain (VAS) (3mo)

P⫽0.5

Grip strength (3mo)

P⫽0.5

Pinch grip (3mo)

P⫽0.6

Levine-Katz questionnaire Symptoms (3mo, 7y)

P⫽0.6

TM Indiana Tome: 1.9 (mean) at 3mo vs open incision: 2.0 at 3mo TM Indiana Tome: 96% (mean) at 3mo vs open incision: 94% at 3mo TM Indiana Tome: 93% (mean) at 3mo vs open incision: 89% at 3mo TM Indiana Tome: from 17.8 (mean) preoperative to 18.5 at 3mo vs open incision: from 19.3 pre-operative to 17.1 at 3mo TM Indiana Tome*: 16.0 (mean) at 7y vs open incision: 13 at 7y TM Indiana Tome: from 33.9 (mean) preoperative to 18.5 at 3mo vs open incision: from 34.5 preoperative to 19.8 at 3mo TM Indiana Tome: 12 (mean) at 7y vs open incision: 10 at 7y Number of wrists with pillar pain: double incision: 4/19 vs single incision: 12/21 at 3mo follow-up Number of wrists with pillar pain: double incision: 1/19 vs single incision: 8/21 at 6mo follow-up Double incision: mean ⫾ SD, 46⫾10 vs single incision 46⫾8 at baseline Double incision: mean ⫾ SD, 65⫾12 vs single incision 61⫾10 at 3mo follow-up Double incision: mean ⫾ SD, 70⫾16 vs single incision 65⫾16 at 6mo follow-up

P⬍0.05 Levine-Katz questionnaire Function (3mo, 7y)

P⫽0.7

P⫽0.2 Hamed et al68

Open carpal tunnel decompression using the standard singleincision technique (n⫽21)

Open carpal tunnel decompression using a double-incision technique (n⫽19)

Results by Outcome Measure

Decompression of the median nerve by open carpal tunnel release without perineural corticosteroid injection (n⫽20)

Pillar pain (6mo)

P⫽0.04

P⫽0.03

Grip strength (6mo)

P⫽1.0

P⫽0.25

P⫽0.45

Abbreviations: CTD, carpal tunnel decompression; NS not significant; PEM, Patient Evaluation Measure. *In favor of. † Follow-up data of the study of Cellocco et al50 reported in the Cochrane review of Scholten et al.20 ‡ Groups not compared between groups (ie, only compared within groups).

APPENDIX 4: ADDITIONAL RCTs: CTS Author Ucan et al26

Treatment

Placebo

Surgical vs nonsurgical Splinting in neutral position with standard cottonpolyester, day and night for 3mo (group 1; n⫽23)


Control/Comparison

Local steroid injection into the carpal tunnel (20mg triamcinolone acetonide and 20mg lidocaine) after 3mo of splinting (group 2) (n⫽23) Open carpal tunnel release (group 3; n⫽11)

Outcome Measures (total FU time)

Boston QuestionnaireSymptom severity scale (6mo)


NS, no P value given

P⫽.004

Results by Outcome Measure Group 1: from mean ⫾ SD, 2.66⫾.35 at baseline to 1.39⫾.37 at 3mo vs group 2: from 2.79⫾.63 at baseline to 1.41⫾.32 at 3mo vs group 3: from 3.09⫾0.5 at baseline to 1.86⫾0.6 at 3mo Group 1: from mean ⫾ SD, 2.66⫾.35 at baseline to 1.54⫾.31 at 6mo vs group 2: from 2.79⫾.63 at baseline to 1.96⫾.63 at 6mo vs group 3*: from 3.09⫾0.5 at baseline to 1.41⫾.31 at 6mo


1019

APPENDIX 4: ADDITIONAL RCTs: CTS (Cont’d) Author

Treatment

Placebo

Control/Comparison

Outcome Measures (total FU time) BQ- Function capacity scale (6mo)

Results—Statistical NS, no P value given

P⫽.03

Padua et al55

Kharwadkar et al69

Various surgical techniques Release of the transverse carpal ligament with corticosteroid irrigation of the median nerve before skin closure (n⫽10)

Sutures in surgery Absorbable sutures: polyglactin 910 ⫽ vicryl (n⫽18)

Release of the transverse carpal ligament without corticosteroid irrigation of the median nerve (n⫽10)

Nonabsorbable sutures polypropylene ⫽ prolene (n⫽18)

Levine Questionnaire Symptom severity scale (60d)

P⫽.005

Function severity scale (60d)


Severity of pillar pain (VAS) (12wk)

P⬎.05

Absorbable group: all hands, mean ⫾ SD, 0⫾0 vs nonabsorbable group: 14 hands, 0⫾0, 4 hands, 3.0⫾0.5

P⫽.152

Absorbable group: from mean ⫾ SD, 2.8⫾.58 at baseline to 1.1⫾.25 at 12wk follow-up vs nonabsorbable: from 2.8⫾.61 at baseline to 1.1⫾.21 at 12wk follow-up Absorbable group: from mean ⫾ SD, 2.0⫾.82 at baseline to 1.1⫾.39 at 12wk follow-up vs nonabsorbable: from 2.0⫾.54 at baseline to 1.1⫾.69 at 12wk follow-up 10d: vicryl group: 25 comfortable, 4 uncomfortable, 1 painful, vs prolene group*: 14 comfortable, 14 uncomfortable, 0 painful 6wk: no data given Vicryl group: 17 residual pain, 14 no residual pain, 1 not known, vs prolene group: 9 residual pain, 20 no residual pain, 3 not known No exact data given

Boston Questionnaire Symptom severity score (12wk)

Erel et al71

Menovsky et al70

Absorbable sutures: polyglactin 910 ⫽ vicryl (n⫽32)

Absorbable sutures: polyglactin 910 ⫽ vicryl (n⫽25)

Nonabsorbable sutures: polypropylene ⫽ prolene (n⫽32)

Sutures: nylon (n⫽17) or sutures: stainless steel (n⫽19)

Results by Outcome Measure Group 1: from mean ⫾ SD, 2.47⫾.65 at baseline to 1.60⫾0.2 at 3mo vs group 2: from 2.19⫾.51 at baseline to 1.32⫾.33 at 3mo vs group 3: from 2.7⫾.62 at baseline to 1.85⫾.63 at 3mo Group 1: from mean ⫾ SD, 2.47⫾.65 at baseline to 1.75⫾.26 at 6mo vs group 2: from 2.19⫾.51 at baseline to 1.69⫾.31 at 6mo vs group 3*: from 2.7⫾.62 at baseline to 1.52⫾.34 at 6mo

Functional status scale (12wk)

P⫽0.719

Pain levels (6wk)

P⫽.016

Residual pain (6wk)


CTS symptoms (tingling of the fingers, persistent numbness, pain) Pain after surgery (VAS) (6wk)

NS, no P value given NS, no P value given

Steroid treatment group*: from mean ⫾ SD (95% CI), 44.8⫾6.0 (41.0–48.6) at baseline to 11.8⫾1.3 (10.8– 12.7) at 60d vs controls: from 41.8⫾5.4 (37.6–45.9) at baseline to 19.4⫾2.1 (17.8– 21.1) at 60d Steroid treatment group: from mean ⫾ SD (95% CI), 28.8⫾9.2 (22.3–34.1) at baseline to 9.00⫾1.6 (7.9– 10.1) at 60d vs controls: from 26.9⫾9.2 (19.8–34.0) at baseline to 15.4⫾1.3 (14.4– 16.5) at 60d

Vicryl group: mean ⫾ SD, 3.4⫾2.6 vs nylon group: 3.6⫾3.1 vs steel group: 2.7⫾2.1†


1020


APPENDIX 4: ADDITIONAL RCTs: CTS (Cont’d) Author Cook et al72

Treatment

Placebo

Preoperative treatment A volar splint in neutral position for 2wk pre-operative: open carpal tunnel release (finger movement allowed); after Surgery, 2wk splinting (n⫽25)

Control/Comparison

A bulky dressing for 2 wk preoperative (open carpal tunnel release); after surgery, unrestricted active movement was allowed (n⫽25)



Subjective pain (6mo)

P⫽.01

Grip strength (6mo)

NS, no P value given P⫽.02

Key pinch strength (6mo)

NS, no P value given P⫽.01 NS, no P value given

Bury et al73

Finsen et al74

Postoperative treatment Splinting Bulky dressing and splinting in a 0° or neutral wrist position for 2wk after carpal tunnel release (3cm parathenar longitudinal incision; n⫽26) 48h after open carpal tunnel release, a plaster of Paris splint in slight dorsiflexion for 4wk (n⫽37)

Only a bulky dressing for 2wk after carpal tunnel release (3cm parathenar longitudinal Incision; n⫽17)

48h after open carpal tunnel release, a very light dressing for 4wk (n⫽45)

Grip strength (6mo)

P⬎.05

Lateral pinch strength (6mo) Range of motion of the wrist in flexionextension (°) (6mo) Pain (VAS) (6mo)

P⬎.05 NS, no P value given NS, no P value given


Martins et al75

Huemer et al76

48h after open carpal tunnel release, a splint in neutral position for 2 wk (n⫽26)

Volar splint in neutral position for 48h after standard open carpal tunnel release (n⫽25)


No splint 48h after open carpal tunnel release (n⫽26)

No splint (light bandage) for 48h after standard open carpal tunnel release (n⫽25)

Grip strength (6mo) (expressed as percentage of preoperative results)


Key pinch (6mo) (expressed as percentage of preoperative results)


Boston Questionnaire (symptom severity index) (2wk) Symptom intensity index (tingling, burning, pain, numbness; 2wk) Pain (VAS) (3mo)

P⫽.059



P⫽.386


Grip strength (3mo)


Pick-up test (3mo)


Results by Outcome Measure

Splint*: 1.5 (mean) vs no splint: 0.5 at 1mo Pain at 6mo after surgery; no exact data given Splint: 14kg (mean) vs no splint*: 18kg at 1mo Grip strength at 6mo after surgery, no exact data given Splint*: 5kg (mean) vs no splint: 7kg at 1 mo Key pinch strength at 6mo after surgery, no exact data given

Splint: 26.1 (mean) vs no splint: 29.4 Splint: 3.9 (mean) vs no splint: 3.8 Splint: 131.5 (mean) vs no splint: 129.0 Splint: from median (95% CI), 56 (46–65) pre-operative to 6 (4–20) at 6wk vs no splint: 51 (38–57) preoperative to 2 (2–4) at 6wk Splint: median (95% CI), 3 (2– 8) vs no splint: 2 (0–4) at 6mo Splint: median (95% CI), 76% (71–85) vs no splint: 78% (70–86) at 6wk Splint: median (95% CI), 104% (94–115) vs no splint: 108% (100–116) at 6mo Splint: median (95% CI), 86% (80–92) vs no splint: 83% (76–92) at 6wk Splint: median (95% CI), 93% (83–100) vs no splint: 92% (84–100) at 6mo Splint group: mean ⫾ SD, .64⫾.15 vs no splint group: 0.61⫾.12 Splint group: mean ⫾ SD, .91⫾.15 vs no splint group: .80⫾.27 Splint group: preoperative 5 (mean) to 1 after 3 mo follow-up vs no-splint group: preoperative 4 to 1 after 3mo follow-up Splint group: preoperative 50kg (mean) to 44kg after 3mo follow-up vs no-splint group: preoperative 47kg to 40kg after 3mo follow-up Splint group: preoperative 21s (mean) to 19s after 3mo follow-up vs no-splint group: pre-operative 19s to 17s after 3mo follow-up


1021

APPENDIX 4: ADDITIONAL RCTs: CTS (Cont’d) Author Cebesoy et al77

Provinciali et al78

Pomerance et al79

Treatment

Placebo

Control/Comparison

Exercise Multimodal rehabilitation training after carpal tunnel surgery beginning after the day the stitches were removed (12d after surgery) for 2wk (n⫽50)

Postoperative 2-wk hand therapy by a therapist (n⫽73)


Levine Questionnaire Function severity scale (3mo)

P⫽.023

Functional status scale (3mo)

P⫽.190

Home exercise program after carpal tunnel surgery beginning after the day the stitches were removed (12d after surgery) for 2wk (n⫽50)

Boston Carpal Tunnel Questionnaire (2mo)


Jebsen-Taylor test (2 mo)


Nine-hole peg test (2 mo)


Postoperative home therapy exercises without supervision (n⫽77)

Pain (VAS) (3mo)

P⬎.05

Grip/pinch strength (kg) (dynamometer)

Not applicable

No splint (bandage) and immediately standard physical exercises after standard open carpal tunnel release (n⫽20)

Splint after standard open carpal tunnel release for 10d; after this, 10d standard physical exercises (n⫽20)


P⬎.05

P⬎.05

Stevinson et al80

Jeffrey et al81

Hochberg et al82

Chaise et al83

Arnica Arnica 6 C (n⫽20) or arnica 30 C (n⫽20) 3 times daily 7d before surgery and 2wk after surgery Arnica pills and ointment after surgery (n⫽20) 3 times daily for 2wk

No difference between the 2 groups No exact data given No difference between the 2 groups No exact data given No difference between the 2 groups No exact data given Both groups: from preoperative: 6 of 10 to post operative: 1 of 10 (no exact follow-up time given) Preoperative: Total of the study group: mean ⫾ SD, 25.5 (10.8)/7.4 (2.3), no data given for each treatment group separately 3mo: Hand therapy group: 26.0 (8.9)/7.5 (2.3) vs home exercise group: 26.6 (8.8)/7.7 (2.5) 6mo: Hand therapy group: 26.2 (10.0)/7.6 (2.3) vs home exercise group: 26.6 (9.9)/7.8 (2.3) Hand therapy group vs home exercise group: no exact data given

DASH

P⬎.05

(n⫽22)

Pain after surgery (VAS) (2wk)


Arnica 6 C: median (range), 0.0 (0–28) vs arnica 30 C: 2.0 (0–41) vs placebo: 8.5 (0–45)

(n⫽17)

Hand discomfort (VAS) (2wk) Grip strength (% change) (2wk)

P⬍0.03

Arnica group*: 1.3 (mean) vs placebo: 2.5 Arnica group: mean ⫾ SD, 100.2⫾63 vs placebo: 94.8⫾41.7

Pain after surgery (VAS) (3d)

NS, no P value given P⬍.001 P⫽.005 P⬍.05

Other postoperative treatments CCT after surgery (monitoring temperature; n⫽36) Naftidrofuryl 400 mg after surgery (n⫽?/195)

Results by Outcome Measure Splint group: preoperative 37.75 (mean) to 13.50 after 3mo follow-up vs no splint group*: pre-operative 36.32 to 11.90 after 3mo follow-up Splint group: preoperative 26.60 (mean) to 10.65 after 3mo follow-up vs no splint group: pre-operative 26.11 to 10.26 after 3mo follow-up

CIT after surgery (icepack; n⫽36)

(n⫽?/195)

Pain (30d)


CCT: mean change ⫾ SD, ⫺3.2⫾4.1 vs CIT: ⫺1.8⫾3.2 Within CCT Within CIT Naftidrofuryl*: 72% no/almost no pain; 19% little pain; 9% mean/heavy pain vs placebo: 66% no/almost no pain; 15% little pain; 19% mean/heavy pain

Abbreviations: ?, unknown number; CCT, controlled cold therapy; CIT, conventional ice therapy; DASH, Disabilities of the Arm, Shoulder and Hand; NS not significant. *In favor of. † Between groups not compared (ie, only within groups).

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