Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial

Margreet Meems, Brenda Den Oudsten, Berend-Jan Meems, Victor Pop, Margreet Meems, Brenda Den Oudsten, Berend-Jan Meems, Victor Pop

Abstract

Background: Carpal tunnel syndrome (CTS) is a common condition (prevalence of 4%) where the median nerve is compressed within the carpal tunnel resulting in numbness, tingling, and pain in the hand. Current non-surgical treatment options (oral medication, corticosteroid injections, splinting, exercise, and mobilization) show limited effects, especially in the long-term. Carpal tunnel release (CTR) surgery is effective in 70 to 75% of patients, but is relatively invasive and can be accompanied by complications. In an observational study, mechanical traction proved to be effective in up to 70% of patients directly after treatment and in 60% after two years follow-up. This randomized controlled trial (RCT) will examine the effectiveness of mechanical traction compared to care as usual in CTS.

Methods/design: Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group (mechanical traction) or the control group (care as usual). Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Primary outcome is symptom severity and functional status, which are measured with the Boston Carpel Tunnel Questionnaire (BCTQ). Secondary outcomes are quality of life (WHOQOL-BREF), health related resource utilization, and absenteeism from work. Outcomes will be assessed at baseline, and at 3, 6, and 12 months after inclusion. Linear mixed effect models will be used to determine the change from baseline at 12 months on the BCTQ, WHOQOL-BREF, absenteeism from work and health related resource utilization. The baseline measurement, change from baseline at three and six months, as well as duration of symptoms until inclusion, age, gender, and co-morbidity will be included as covariates The Pearson's correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome.

Discussion: Since current non-surgical treatment options are not effective long-term and CTR is relatively invasive, there is a need for an effective and non-invasive treatment option. Mechanical traction is a safe treatment option that may provide a good alternative for the usual care. Considering the prevalence of CTS, the study is of great clinical value to a large patient population.

Trial registration: Clinical Trials NL44692.008.13 (registered on 19 September 2013).

References

    1. Ibrahim I, Khan WS, Goddard N, Smitham P. Carpal tunnel syndrome: a review of the recent literature. Open Orthop J. 2012;6:69–76. doi: 10.2174/1874325001206010069.
    1. Dawson DM. Entrapment neuropathies of the upper extremities. N Engl J Med. 1993;329(27):2013–2018. doi: 10.1056/NEJM199312303292707.
    1. Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999;282(2):153–158. doi: 10.1001/jama.282.2.153.
    1. Spahn G, Wollny J, Hartmann B, Schiele R, Hofmann GO. Metaanalysis for the evaluation of risk factors for carpal tunnel syndrome (CTS) Part II. Z Orthop Unfall. 2012;150(5):516–524.
    1. Barcenilla A, March LM, Chen JS, Sambrook PN. Carpal tunnel syndrome and its relationship to occupation: a meta-analysis. Rheumatology. 2012;51(2):250–261. doi: 10.1093/rheumatology/ker108.
    1. Nunez F, Vranceanu AM, Ring D. Determinants of pain in patients with carpal tunnel syndrome. Clin Orthop Relat Res. 2010;468(12):3328–3332. doi: 10.1007/s11999-010-1551-x.
    1. Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011;44(4):597–607. doi: 10.1002/mus.22208.
    1. Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, Middelkoop Van M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments - -a systematic review. Archives Physical Med Rehabilitation. 2010;91(7):981–1004. doi: 10.1016/j.apmr.2010.03.022.
    1. Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007;2 CD001554.
    1. Page MJ, Massy-Westropp N, O'Connor D, Pitt V. Splinting for carpal tunnel syndrome. Cochrane Database Syst Rev. 2012;7 CD010003.
    1. Page MJ, O'Connor D, Pitt V, Massy-Westropp N. Exercise and mobilisation interventions for carpal tunnel syndrome. Cochrane Database Syst Rev. 2012;6 CD009899.
    1. O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;1 CD003219.
    1. Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-De Jong B. Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice. BMC Fam Pract. 2010;11:54. doi: 10.1186/1471-2296-11-54.
    1. Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009;374(9695):1074–1081. doi: 10.1016/S0140-6736(09)61517-8.
    1. Huisstede BM, Randsdorp MS, Coert JH, Glerum S, Middelkoop Van M, Koes BW. Carpal tunnel syndrome. Part II: effectiveness of surgical treatments - -a systematic review. Archives Physical Med Rehabilitation. 2010;91(7):1005–1024. doi: 10.1016/j.apmr.2010.03.023.
    1. Neuhaus V, Christoforou D, Cheriyan T, Mudgal CS. Evaluation and treatment of failed carpal tunnel release. Orthop Clin North America. 2012;43(4):439–447. doi: 10.1016/j.ocl.2012.07.013.
    1. Uchiyama S, Itsubo T, Nakamura K, Kato H, Yasutomi T, Momose T. Current concepts of carpal tunnel syndrome: pathophysiology, treatment, and evaluation. J Orthop Sci. 2010;15(1):1–13. doi: 10.1007/s00776-009-1416-x.
    1. Brunarski DJ, Kleinberg BA, Wilkins KR. Intermittent axial wrist traction as a conservative treatment for carpal tunnel syndrome: a case series. J Can Chiropr Association. 2004;48(3):211–216.
    1. Kloosterman IA. Research into the effect of the treatment of the carpal tunnel syndrome with the Phystrac traction device. .
    1. Kloosterman IA. Onderzoek naar het lange termijn effect van de behandeling van het carpaal tunnel syndroom met het Phystrac tractie apparaat. .
    1. Leite JC, Jerosch-Herold C, Song F. A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskelet Disord. 2006;7:78. doi: 10.1186/1471-2474-7-78.
    1. Ortiz-Corredor F, Calambas N, Mendoza-Pulido C, Galeano J, Diaz-Ruiz J, Delgado O. Factor analysis of carpal tunnel syndrome questionnaire in relation to nerve conduction studies. Clin Neurophysiol: J Int Fed Clin Neurophysiol. 2011;122(10):2067–2070. doi: 10.1016/j.clinph.2011.02.030.
    1. Hoefnagels WA, Van Kleef JG, Mastenbroek GG, de JA B, Breukelman AJ, Krom De MC. Surgical treatment of carpal tunnel syndrome: endoscopic or classical (open)? A prospective randomized trial. Nederlands Tijdschrift Voor Geneeskunde. 1997;18:878–882.
    1. Trompenaars FJ, Masthoff ED, Van Heck GL, Hodiamont PP, De Vries J. Content validity, construct validity, and reliability of the WHOQOL-Bref in a population of Dutch adult psychiatric outpatients. Qual Life Res. 2005;14(1):151–160. doi: 10.1007/s11136-004-0787-x.
    1. Skevington SM, Lotfy M, O'Connell KA. Group W. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Quality Life Res. 2004;13(2):299–310.
    1. Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brähler E. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affective Disorders. 2010;122(1–2):86–95.
    1. Mallinckrodt CH, Sanger TM, Dube S, DeBrota DJ, Molenberghs G, Carroll RJ, Potter WZ, Tollefson GD. Assessing and interpreting treatment effects in longitudinal clinical trials with missing data. Biol Psychiatry. 2003;53(8):754–760. doi: 10.1016/S0006-3223(02)01867-X.
    1. West BT, Welch KB, Galecki AT. Linear Mixed Models: A Practical Guide Using Statistical Software. Boca Raton: Taylor & Francis; 2006.
    1. Bekkelund SI, Pierre-Jerome C, Torbergsen T, Ingebrigtsen T. Impact of occupational variables in carpal tunnel syndrome. Acta Neurol Scand. 2001;103(3):193–197. doi: 10.1034/j.1600-0404.2001.103003193.x.
    1. Mallick A, Clarke M, Wilson S, Newey ML. Reducing the economic impact of carpal tunnel surgery. J Hand Surg Eur Vol. 2009;34(5):679–681. doi: 10.1177/1753193409105578.
    1. Foley M, Silverstein B, Polissar N. The economic burden of carpal tunnel syndrome: long-term earnings of CTS claimants in Washington State. American J Industrial Med. 2007;50(3):155–172. doi: 10.1002/ajim.20430.
    1. Wade JB, Dougherty LM, Archer CR, Price DD. Assessing the stages of pain processing: a multivariate analytical approach. Pain. 1996;68(1):157–167. doi: 10.1016/S0304-3959(96)03162-4.
    1. Hobby JL, Venkatesh R, Motkur P. The effect of psychological disturbance on symptoms, self-reported disability and surgical outcome in carpal tunnel syndrome. J Bone Joint Surg Br. 2005;87(2):196–200.
    1. Lozano Calderon SA, Paiva A, Ring D. Patient satisfaction after open carpal tunnel release correlates with depression. J Hand Surgery. 2008;33(3):303–307. doi: 10.1016/j.jhsa.2007.11.025.

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