Treatment of carpal tunnel syndrome with wrist splinting: study protocol for a randomized placebo-controlled trial.

BACKGROUND: Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually during night-time, for several weeks. Evidence regarding the efficacy and effect durability of wrist splinting is weak. The treatment is associated with costs and may cause discomfort and limit daily and work activities. No placebo-controlled trials have been performed. METHODS: 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. The trial will be conducted at an orthopedic department. 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. Patients who fulfill the trial's eligibility criteria will be invited to participate. 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. The splints and bandages will be fitted with a temperature-monitoring device to measure the total time during which they have actually been worn. 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 participants will undergo physical examination and nerve conduction testing at baseline and at 52 weeks. 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN81836603 . Registered on May 5, 2018.

Incidence of referred carpal tunnel syndrome and carpal tunnel release surgery in the general population: Increase over time and regional variations.

PURPOSE: To investigate the change in incidence of referred carpal tunnel syndrome (CTS) and carpal tunnel release (CTR) surgery over time and regional variations. METHODS: From the nationwide patient registry, we identified all adult individuals who had received first-time CTS diagnosis (International Classification of Diseases, 10th Revision code G560) at secondary or tertiary level and first-time CTR surgery during the period of 9 years. RESULTS: From 2001 through 2009, the incidence (per 100,000 person-years) of CTS diagnosed at secondary or tertiary level increased from 216 to 243 in women and from 95 to 119 in men and of CTR from 117 to 168 in women and from 52 to 78 in men. The mean annual increase in first-time CTR (95% confidence interval) was 5.1% (4.7-5.4) in women and 6.2% (5.6-6.7) in men. The age-standardized 3-year (2007-2009) incidence varied significantly across Sweden's 21 counties; compared to the county with the lowest incidence of CTR, the incidence rates in the other counties were higher by 6-152% (mean 60%) in women and by 20-182% (mean 85%) in men. The proportion of CTS-diagnosed individuals treated with surgery varied across counties from 53% to 81% in women and from 51% to 77% in men. CONCLUSION: The incidence of referred CTS and of CTR surgery increased over time in both sexes, with large regional variations found in the incidence rates and in the proportion of individuals treated with surgery.

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review.

BACKGROUND: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. METHODS: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann-Whitney test. RESULTS: The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck's disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0-1) and for the shoulder RCTs 3.0 (range 0-5) (p = 0.012). CONCLUSION: Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy.