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

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).