![]() This is the first placebo-controlled randomized trial with electronic monitoring of actual splint use and will provide evidence regarding the efficacy of wrist splinting in patients with CTS. The trial’s primary outcomes are the change in the CTS-6 score from baseline to 12 weeks and the rate of carpal tunnel release surgery at 52 weeks. The participants will undergo physical examination and nerve conduction testing at baseline and at 52 weeks. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6) the 11-item disabilities of the arm, shoulder, and hand ( QuickDASH) scale and the EuroQol 5-dimension (EQ-5D) health status and quality-of-life measure at baseline and at 6, 12, 24, and 52 weeks after treatment start. The splints and bandages will be fitted with a temperature-monitoring device to measure the total time during which they have actually been worn. A total of 112 patients who provide informed consent will be randomly assigned to treatment with either a rigid wrist splint or a soft bandage to be used initially for 6 weeks at night and, if possible, during the day. Patients who fulfill the trial’s eligibility criteria will be invited to participate. Patients, 25 to 65 years old, who seek primary health-care with symptoms of CTS will be screened, and potentially eligible patients will be referred to the study center. The trial will be conducted at an orthopedic department. This is a randomized controlled trial designed to assess the efficacy of a rigid wrist splint compared with soft wrist bandage (placebo) in patients with primary idiopathic CTS. No placebo-controlled trials have been performed. ![]() The treatment is associated with costs and may cause discomfort and limit daily and work activities. Evidence regarding the efficacy and effect durability of wrist splinting is weak. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually during night-time, for several weeks. Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations.
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