TREATMENT OF CARPAL TUNNEL SYNDROME EVIDENCE REPORT This Clinical Practice Guideline Evidence Report was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline Evidence Report is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. This Clinical Practice Guideline Evidence Report and the associated Clinical Practice Guideline were funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document. All panel members gave full disclosure of conflicts of interest prior to voting on the recommendations contained within the guidelines. This Clinical Practice Guideline Evidence Report received no financial support from industry sponsors. TABLE OF CONTENTS I. INTRODUCTION........................................................................................1 Overview.......................................................................................................................................................1 Documentation of Approval Process...........................................................................................................1 Description of Committees and Council.....................................................................................................1 II. METHODS.................................................................................................2 Types of Studies............................................................................................................................................2 Article Inclusion and Exclusion Criteria....................................................................................................3 Exclusion Criteria......................................................................................................................................4 Inclusion Criteria.......................................................................................................................................4 Literature Search.........................................................................................................................................5 Data Extraction.............................................................................................................................................6 Study Characteristics.................................................................................................................................6 Patient Characteristics...............................................................................................................................6 Results.......................................................................................................................................................6 Assigning a Level of Evidence.....................................................................................................................7 Types of Outcome Measures........................................................................................................................7 Peer Review of the Guideline.......................................................................................................................8 Statistical Methods.......................................................................................................................................8 Grading the Recommendations.................................................................................................................10 III. RESULTS................................................................................................11 Recommendation 1.....................................................................................................................................12 Recommendation 2.....................................................................................................................................13 Recommendation 3.....................................................................................................................................14 CTS in the Workplace.............................................................................................................................14 Pregnancy................................................................................................................................................14 Coexistent Cervical Radiculopathy..........................................................................................................15 ii Recommendation 4.....................................................................................................................................16 Studies with Greater than 20% Bilateral Patients....................................................................................16 Studies with Multiple Comparisons.........................................................................................................16 Splinting vs. No Treatment......................................................................................................................24 Full-time vs. Nocturnal Splinting............................................................................................................27 Yoga vs. Splinting...................................................................................................................................28 Nerve and Tendon Exercise plus Splinting vs. Splinting Alone..............................................................29 Ultrasound vs. Placebo............................................................................................................................31 Laser Therapy and Wrist Splint vs. Wrist Splint and Placebo Laser.......................................................33 Laser Acupuncture vs. Placebo or Steroid Injection................................................................................34 Ultrasound vs. Laser................................................................................................................................36 Ultrasound plus Oral Placebo vs. NSAIDs plus Placebo Ultrasound......................................................37 Oral Steroid vs. Placebo..........................................................................................................................38 Diuretic vs. Placebo.................................................................................................................................39 NSAIDs vs. Placebo................................................................................................................................41 NSAIDs vs. Oral Steroids........................................................................................................................42 Oral Placebo vs. Heat Therapy................................................................................................................43 Oral Steroids vs. Diuretics.......................................................................................................................44 NSAIDs vs. Diuretics..............................................................................................................................45 Vitamin B vs. Placebo.............................................................................................................................46 Therapeutic Touch vs. Sham Treatment..................................................................................................47 Chiropractic vs. Medical Treatment........................................................................................................48 Graston Instrument vs. Clinician Hands..................................................................................................49 Steroid Injection vs. Placebo...................................................................................................................50 Oral Steroid vs. Steroid Injection............................................................................................................52 Local Steroid Injection vs. Systemic Injection........................................................................................53 Steroid Injection vs. Iontophoresis..........................................................................................................55 Steroid Injection vs. Phonophoresis.........................................................................................................56 Steroid Injection vs. Splinting plus NSAIDs...........................................................................................57 Proximal or Distal Steroid Injection vs. Splinting...................................................................................58 Steroid Injection plus Splinting vs. Splinting Alone................................................................................59 Steroid Injection Position........................................................................................................................60 Iontophoresis vs. Phonophoresis..............................................................................................................61 Open Carpal Tunnel Release vs. Splinting..............................................................................................62 Open Carpal Tunnel Release vs. Local Steroid Injection plus Splinting.................................................63 Steroid Injection vs. Open Carpal Tunnel Release..................................................................................65 Conservative Treatments with No Controlled Trials Meeting Inclusion Criteria....................................67 Recommendation 5.....................................................................................................................................68 Open vs. Endoscopic...............................................................................................................................69 OCTR vs. ECTR - Pain.......................................................................................................................70 OCTR vs. ECTR - All Complications.................................................................................................71 OCTR vs. ECTR - Infection...............................................................................................................72 OCTR vs. ECTR - Reversible Nerve Damage....................................................................................73 OCTR vs. ECTR - Wound Related Complications.............................................................................74 OCTR vs. ECTR - Functional Status (FSS) at 12 weeks....................................................................75 OCTR vs. ECTR - Functional Status (FSS) at 52 weeks....................................................................76 OCTR vs. ECTR - Symptom severity (SSS) at 12 weeks...................................................................77 OCTR vs. ECTR - Symptom severity (SSS) at 52 weeks...................................................................78 OCTR vs. ECTR - Return to Work.....................................................................................................79 OCTR vs. ECTR - Grip Strength........................................................................................................80 OCTR vs. ECTR - Pinch Strength......................................................................................................81 OCTR vs. Minimal Incision.....................................................................................................................82 ECTR vs. Minimal Incision.....................................................................................................................86 iii Recommendation 6.....................................................................................................................................88 Synovectomy...........................................................................................................................................90 Internal Neurolysis...................................................................................................................................91 Epineurotomy..........................................................................................................................................92 Ulnar Bursa Preservation.........................................................................................................................93 Skin Nerve Preservation..........................................................................................................................94 Flexor Retinaculum Lengthening............................................................................................................95 Recommendation 7.....................................................................................................................................96 Infection Rates.........................................................................................................................................96 Infection in Immunosuppressed Patients - Diabetics...............................................................................97 Infection in Adjuvant Methods................................................................................................................98 Tenosynovectomy...............................................................................................................................98 Epineurotomy......................................................................................................................................98 Ulnar Bursa Preservation....................................................................................................................99 Flexor Retinaculum Lengthening......................................................................................................100 Recommendation 8...................................................................................................................................101 Bowstringing.........................................................................................................................................103 Post-Operative Splinting vs. No Post-Operative Splinting Results from Martins et al..........................104 Post-Operative Splinting vs. No Post-Operative Splinting Results from Finsen et al...........................105 Post-Operative Splinting vs. No Post-Operative Splinting Results from Bury et al..............................106 Post-Operative Splinting vs. No Post-Operative Splinting Results from Cook et al.............................107 Post-Op Physiotherapy vs. No Post-Op Physiotherapy Results from Provinciali et al..........................110 Recommendation 9...................................................................................................................................111 Inclusion Criteria...................................................................................................................................111 Literature Search....................................................................................................................................111 Instruments............................................................................................................................................111 Study Quality.........................................................................................................................................112 Study Generalizability...........................................................................................................................112 Study Reliability....................................................................................................................................113 Internal Consistency..........................................................................................................................113 Reproducibility.................................................................................................................................114 Study Validity........................................................................................................................................115 Construct Validity.............................................................................................................................115 Convergent Validity..........................................................................................................................115 Discriminant Validity........................................................................................................................115 Criterion Validity..............................................................................................................................115 Study Responsiveness............................................................................................................................116 References.................................................................................................................................................126 Bibliography of Included Studies............................................................................................................128 Bibliography of Excluded Studies...........................................................................................................136 iv IV. APPENDIXES........................................................................................155 Appendix A: Work Group.......................................................................................................................156 Appendix B: Literature searches............................................................................................................157 Original Search for Systematic Reviews...............................................................................................157 Search for Primary Studies From Systematic Reviews..........................................................................158 Marshall et al....................................................................................................................................158 O’Connor et al..................................................................................................................................158 Scholten et al.....................................................................................................................................159 Verdugo et al.....................................................................................................................................159 Search Strategies for Recommendations without Relevant Systematic Reviews..................................160 Recommendation 3...........................................................................................................................160 Recommendation 7...........................................................................................................................160 Recommendation 8...........................................................................................................................160 Recommendation 9...........................................................................................................................161 Appendix C: Flowcharts..........................................................................................................................162 Recommendations 1,2,3,4......................................................................................................................163 CTS in the Workplace.......................................................................................................................167 Coexistent Cervical Radiculopathy...................................................................................................168 Recommendations 5 and 6.....................................................................................................................169 Recommendation 7................................................................................................................................170 Recommendation 8................................................................................................................................171 Recommendation 9................................................................................................................................172 Appendix D: Levels of Evidence..............................................................................................................173 Appendix E: Form for Assigning Grade of Recommendation (Interventions)...................................174 Appendix F: Voting by the Nominal Group Technique........................................................................176 V. EVIDENCE TABLES .............................................................................177 See Evidence Tables Document (Evidence Tables.pdf).........................................................................177 List of Tables.............................................................................................................................................177 v Figures Figure 1. Evolution of CTS after Pregnancy....................................................................14 Figure 2. Evolution in Pain...............................................................................................15 Figure 3. FSS Splinting vs. No Treatment........................................................................24 Figure 4. SSS Splinting vs. No Treatment........................................................................25 Figure 5. Patient Satisfaction with Treatment (log OR); Splinting vs. No Treatment......25 Figure 6. Patient Satisfaction with Treatment (OR); Splinting vs. No Treatment............26 Figure 7. Nocturnal Splinting vs. Full Time Splinting.....................................................27 Figure 8. Yoga vs. Splinting.............................................................................................28 Figure 9. Nerve and Tendon Exercise plus Splinting vs. Splinting Alone.......................29 Figure 10. Patient Satisfaction (OR) Exercises plus Splinting vs. Splinting Alone.........29 Figure 11. Patient Satisfaction (log OR) Exercises plus Splinting vs. Splinting Alone...30 Figure 12. Ultrasound vs. Placebo....................................................................................31 Figure 13. 1.5 w/cm2 vs. Placebo Ultrasound...................................................................31 Figure 14. 0.8 w/cm2 vs. Placebo Ultrasound...................................................................32 Figure 15. Ultrasound of Varying Frequencies.................................................................32 Figure 16. Laser Therapy plus Splint vs. Placebo Laser plus Splint................................33 Figure 17. Helium-Neon Laser vs. Placebo Laser............................................................34 Figure 18. Helium-Neon Laser vs. Placebo Laser (log OR).............................................34 Figure 19. Symptom Improvement (log OR) Steroid Injection vs. Helium-Neon Laser.35 Figure 20. Symptom Improvement (OR) Steroid Injection vs. Helium-Neon Laser........35 Figure 21. Laser vs. Ultrasound........................................................................................36 Figure 22. Ultrasound plus Oral Placebo vs. NSAIDs plus Placebo Ultrasound.............37 Figure 23. Oral Steroid vs. Placebo..................................................................................38 Figure 24. GSS - Oral Steroid vs. Placebo........................................................................38 Figure 25. Symptom Improvement (OR) Diuretic vs. Placebo........................................39 Figure 26. Symptom Improvement (log OR) Diuretic vs. Placebo..................................39 Figure 27. GSS - Diuretics vs. Placebo............................................................................40 Figure 28. GSS - NSAIDs vs. Placebo.............................................................................41 Figure 29. GSS - NSAIDs vs. Oral Steroids.....................................................................42 Figure 30. Oral Placebo vs. Heat Therapy........................................................................43 Figure 31. GSS - Oral Steroids vs. Diuretics....................................................................44 Figure 32. GSS - NSAIDs vs. Diuretics...........................................................................45 Figure 33. Vitamin B vs. Placebo.....................................................................................46 Figure 34. Therapeutic Touch vs. Sham Treatment..........................................................47 Figure 35. Medical vs. Chiropractic Treatment................................................................48 Figure 36. Graston Instrument vs. Clinician Hands..........................................................49 Figure 37. Steroid Injection vs. Placebo (log OR)............................................................50 Figure 38. Steroid Injection vs. Placebo (OR)..................................................................50 Figure 39. Clinical Improvement (log OR) Steroid Injection vs. Placebo........................51 Figure 40. Clinical Improvement (OR) Steroid Injection vs. Placebo..............................51 Figure 41. Oral Steroid vs. Steroid Injection....................................................................52 Figure 42. Local Steroid Injection vs. Systemic Injection (log OR)................................53 Figure 43. Local Steroid Injection vs. Systemic Injection (OR).......................................54 Figure 44. Steroid Injection vs. Iontophoresis..................................................................55 Figure 45. Steroid Injection vs. Iontophoresis..................................................................55 vi Figure 46. Steroid Injection vs. Phonophoresis................................................................56 Figure 47. Steroid Injection vs. Splinting plus NSAIDs...................................................57 Figure 48. Proximal Injection vs. Splinting......................................................................58 Figure 49. Distal Injection vs. Splinting...........................................................................58 Figure 50. Splinting plus Local Steroid Injection vs. Splinting Alone.............................59 Figure 51. Distal Steroid Injection vs. Proximal Injection...............................................60 Figure 52. Iontophoresis vs. Phonophoresis.....................................................................61 Figure 53. Clinical Improvement (log OR) Splinting vs. Surgery....................................62 Figure 54. Clinical Improvement (OR) Splinting vs. Surgery..........................................62 Figure 55. Open Carpal Tunnel Release vs. Splinting plus Steroid Injection..................63 Figure 56. Open Carpal Tunnel Release vs. Splinting......................................................64 Figure 57. Open Carpal Tunnel Release vs. Steroid Injection..........................................65 Figure 58. GSS - Open Carpal Tunnel Release vs. Steroid Injection...............................66 Figure 59. OCTR vs. ECTR - No pain at 12 weeks Post-op (log OR).............................70 Figure 60. OCTR vs. ECTR - No pain at 12 weeks Post-op (Cohen’s h)........................70 Figure 61. OCTR vs. ECTR - Complications (all) (log OR)............................................71 Figure 62. OCTR vs. ECTR - Complications (all) (Cohen’s h).......................................71 Figure 63. OCTR vs. ECTR - Infection (log OR).............................................................72 Figure 64. OCTR vs. ECTR - Infection (Cohen’s h)........................................................72 Figure 65. OCTR vs. ECTR - Reversible nerve damage (log OR)...................................73 Figure 66. OCTR vs. ECTR - Reversible nerve damage (Cohen’s h)..............................73 Figure 67. OCTR vs. ECTR - Wound related complications (log OR)............................74 Figure 68. OCTR vs. ECTR - Wound related complications (Cohen’s h).......................74 Figure 69. OCTR vs. ECTR - FSS (3 months).................................................................75 Figure 70. OCTR vs. ECTR - FSS (1 year)......................................................................76 Figure 71. OCTR vs. ECTR - SSS (3 Months).................................................................77 Figure 72. OCTR vs. ECTR - SSS (1 year)......................................................................78 Figure 73. OCTR vs. ECTR - Return to Work.................................................................79 Figure 74. OCTR vs. ECTR - Grip Strength....................................................................80 Figure 75. OCTR vs. ECTR - Pinch Strength...................................................................81 Figure 76. Knifelight vs. OCTR - BCTQ at 19 months....................................................83 Figure 77. Knifelight vs. OCTR - Symptom Relief..........................................................84 Figure 78. Knifelight vs. OCTR - Complications, Scar Tenderness, and Pillar Pain.......84 Figure 79. Knifelight vs. OCTR - Overall Improvement (from Scholten et al)...............85 Figure 80. Minimal Incision vs. ECTR - VAS - Pain.......................................................87 Figure 81. Minimal Incision vs. ECTR - Pillar Pain.........................................................87 Figure 82. Tenosynovectomy - SSS and FSS (from Scholten et al).................................90 Figure 83. Internal Neurolysis - Overall Improvement (from Scholten et al)..................91 Figure 84. Epineurotomy - Overall Improvement (from Scholten et al)..........................92 Figure 85. Epineurotomy - Paraesthesia and Nocturnal Pain at 3 Months.......................92 Figure 86. Ulnar Bursa Preservation - Scar Pain and PEM at 8 weeks............................93 Figure 87. Skin Nerve Preservation - Scar Pain and PEM (Siegmeth et al).....................94 Figure 88. Flexor Retinaculum Lengthening - SSS and FSS (Dias et al).........................95 Figure 89. Infection in Diabetics with CTS......................................................................97 Figure 90. Infection in Ulnar Bursa Preservation.............................................................99 Figure 91. Infection in Flexor Retinaculum Lengthening..............................................100 vii Figure 92. Post-Op Splinting - SSS and 2PD.................................................................104 Figure 93. Post-Op Splinting - VAS Discomfort............................................................105 Figure 94. Post-Op Splinting - Scar Discomfort, Thenar and Hypothenar Pain.............105 Figure 95. Post-Op Splinting - Symptom Free and Patient Satisfaction.........................106 Figure 96. Post-Op Splinting - Return to Work..............................................................107 Figure 97. Post-Op Splinting - Patient Satisfaction........................................................107 Figure 98. Post-Op Splinting - Pain (10 point scale)......................................................108 Figure 99. Post-Op Splinting - Grip and Pinch Strength................................................108 Figure 100. Post-Op Splinting - Pillar Pain and Scar Tenderness..................................109 Figure 101. Post-Op Physiotherapy - SSS and Return to Work.....................................110 Figure 102. Internal Consistency - Reliability in CTS only...........................................113 Figure 103. Reproducibility in CTS only.......................................................................114 Figure 104. SRM of the BCTQ vs. Duration..................................................................117 Figure 105. SRM of the BCTQ SSS vs. Duration..........................................................117 Figure 106. SRM of the BCTQ FSS vs. Duration..........................................................118 Figure 107. Meta-Analysis of BCTQ - FSS Responsiveness at 12-13 weeks................118 Figure 108. SRM of the DASH vs. Duration..................................................................119 Figure 109. Meta-Analysis of DASH Responsiveness at 12-13 weeks..........................119 Figure 110. Responsiveness of SF-36 (subscales)..........................................................120 Figure 111. Responsiveness PEM (subscales)................................................................120 Figure 112. Responsiveness MHQ (subscales)...............................................................121 Figure 113. Responsiveness AIMS2 (subscales)............................................................121 Figure 114. Comparative Responsiveness SF-36, DASH, BCTQ..................................122 Figure 115. Comparative Responsiveness DASH vs. BCTQ FSS and SSS...................122 Figure 116. Comparative Responsiveness SF-36 and BCTQ.........................................123 Figure 117. Comparative Responsiveness PEM and DASH..........................................123 Figure 118. Comparative Responsiveness VAS, DASH and SF-36 (subscales)............124 Figure 119. Comparative Responsiveness AIMS2 and SF-36 (subscales).....................124 Figure 120. Comparative Responsiveness MHQ, DASH, and PEM..............................125 viii Tables Table A. Exclusion Criteria for Included Studies.............................................................12 Table B. Minimum Duration for Effectiveness of Conservative Treatments...................13 Table C. Benefits and Harms for Conservative Treatments.............................................17 Table D. Benefits and Harms for Endoscopic vs. Open Carpal Tunnel Release..............69 Table E. Benefits and Harms for Minimal Incision vs. OCTR.........................................82 Table F. Benefits and Harms for Minimal Incision vs. ECTR.........................................86 Table G. Benefits and Harms for Adjuvant Methods.......................................................89 Table H. Infection Rates from Controlled Trials..............................................................96 Table I. Infection Rates from Other Study Designs..........................................................96 Table J. Infection Rates from All Study Designs.............................................................96 Table K. Infections and Infection Rates for Adjuvant Methods.......................................98 Table L. Benefits and Harms for Post Operative Splinting............................................102 Table M. Bowstringing...................................................................................................103 Table N. Benefits and Harms for Post Operative Physiotherapy....................................110 ix I. INTRODUCTION OVERVIEW This evidence report presents the results of a systematic review of published studies on the treatment of carpal tunnel syndrome (CTS) in adults. It is intended to serve as a companion document to the American Academy of Orthopaedic Surgeons (AAOS) CTS treatment Guideline and an information resource for decision makers and developers of practice guidelines and recommendations. It also should serve to highlight gaps in the literature and areas that require future research. DOCUMENTATION OF APPROVAL PROCESS AAOS Work Group Draft Completed December 2007 Outside Specialty Review Panel Comments Completed April 25, 2008 Public Commentary Completed May 2008 AAOS Guidelines and Technology Oversight Committee June 11, 2008 AAOS Evidence Based Practice Committee June 19, 2008 AAOS Council on Research Quality Assessment July 9, 2008 and Technology AAOS Board of Directors September 12, 2008 A total of 198 professionals were provided the opportunity to comment on the contents of this document during the peer review, public commentary and approval process. Suggested Citation for referencing this document: Treatment of Carpal Tunnel Syndrome. Evidence Report. Rosemont (IL): American Academy of Orthopaedic Surgeons; 2008 DESCRIPTION OF COMMITTEES AND COUNCIL The AAOS Guidelines and Technology Oversight Committee (GTOC) consists of sixteen AAOS members. The overall purpose of this Committee is to oversee the development of the clinical practice guidelines, performance measures, health technology assessments and utilization guidelines. The AAOS Evidence Based Practice Committee (EBPC) consists of ten AAOS members. This Committee provides review, planning and oversight for all activities related to quality improvement in orthopaedic practice, including, but not limited to evidence-based guidelines, performance measures, and outcomes. The GTOC and EBPC report to the Council on Research, Quality Assessment and Technology (CORQAT). CORQAT provides leadership within the AAOS on important and timely issues in musculoskeletal research, clinical quality improvement, and health technology. 1
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