NEJM evidence · 2026
Wrist Splinting versus a Placebo Soft Bandage for Carpal Tunnel Syndrome.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Atroshi Isam, Nordenskjöld Jesper, Möllestam Kamelia
Аннотация
BACKGROUND: Wrist splinting is a common treatment for carpal tunnel syndrome (CTS), but there is little evidence supporting its efficacy.
METHODS: In this parallel-group clinical trial, patients with primary idiopathic CTS with symptoms for at least 1 month and no previous treatment were randomly assigned to wear either a rigid wrist splint or placebo soft bandage (allowed full wrist motion) for 6 weeks. If symptoms persisted after 6 weeks, treatment was continued for 4 more weeks. If symptoms persisted after 12 weeks, surgery was considered. Co-primary outcomes were change in the six-item CTS symptoms score (range 1-5, higher score indicates worse symptoms, minimal clinically important difference, 0.9) from baseline to 12 weeks and proportion of patients undergoing surgery at 1 year. Adverse events were assessed at 6 weeks and 1 year.
RESULTS: Seventy patients were randomly assigned to the rigid splint group and 72 patients to the placebo bandage group. The mean CTS symptoms scores were as follows: rigid splint: baseline, 2.81 and 12 weeks, 2.45 (unadjusted mean difference, -0.36 [95% confidence interval (CI), -0.51 to -0.21]) and placebo bandage: baseline, 2.80 and 12 weeks, 2.52 (unadjusted mean difference, -0.28 [95% CI, -0.45 to -0.11]). The adjusted mean difference in the 12-week change in scores between the two groups was 0.08 (95% CI, -0.15 to 0.31; P=0.478). At 1 year, 40 (57.1%) patients in the rigid splint group and 37 (51.4%) patients in the placebo bandage group had surgery (adjusted relative risk, 1.10 [95% CI, 0.81-1.48]). Minor local adverse events were reported by 12 patients in each group. There were no serious adverse events.
CONCLUSIONS: Among patients with CTS randomly assigned to treatment with a rigid wrist splint versus placebo soft bandage, the change of symptom scores after 12 weeks was not significantly different and the proportion undergoing surgery within 1 year was similar between the two groups. (Funded by a Southern Healthcare Region Research and Development Grant, Swedish Governmental Funding for Clinical Research [ALF], and Lions Foundation Skåne; ISRCTN number, ISRCTN81836603.).
METHODS: In this parallel-group clinical trial, patients with primary idiopathic CTS with symptoms for at least 1 month and no previous treatment were randomly assigned to wear either a rigid wrist splint or placebo soft bandage (allowed full wrist motion) for 6 weeks. If symptoms persisted after 6 weeks, treatment was continued for 4 more weeks. If symptoms persisted after 12 weeks, surgery was considered. Co-primary outcomes were change in the six-item CTS symptoms score (range 1-5, higher score indicates worse symptoms, minimal clinically important difference, 0.9) from baseline to 12 weeks and proportion of patients undergoing surgery at 1 year. Adverse events were assessed at 6 weeks and 1 year.
RESULTS: Seventy patients were randomly assigned to the rigid splint group and 72 patients to the placebo bandage group. The mean CTS symptoms scores were as follows: rigid splint: baseline, 2.81 and 12 weeks, 2.45 (unadjusted mean difference, -0.36 [95% confidence interval (CI), -0.51 to -0.21]) and placebo bandage: baseline, 2.80 and 12 weeks, 2.52 (unadjusted mean difference, -0.28 [95% CI, -0.45 to -0.11]). The adjusted mean difference in the 12-week change in scores between the two groups was 0.08 (95% CI, -0.15 to 0.31; P=0.478). At 1 year, 40 (57.1%) patients in the rigid splint group and 37 (51.4%) patients in the placebo bandage group had surgery (adjusted relative risk, 1.10 [95% CI, 0.81-1.48]). Minor local adverse events were reported by 12 patients in each group. There were no serious adverse events.
CONCLUSIONS: Among patients with CTS randomly assigned to treatment with a rigid wrist splint versus placebo soft bandage, the change of symptom scores after 12 weeks was not significantly different and the proportion undergoing surgery within 1 year was similar between the two groups. (Funded by a Southern Healthcare Region Research and Development Grant, Swedish Governmental Funding for Clinical Research [ALF], and Lions Foundation Skåne; ISRCTN number, ISRCTN81836603.).