OBJECTIVE: No study to our knowledge has investigated the effects longer than 1 year of manual therapy in carpal tunnel syndrome (CTS). The purpose of this study was to investigate the effects of manual therapy versus surgery at 4-year follow-up and to compare the post-study surgery rate in CTS.
METHODS: This randomized controlled trial was conducted in a tertiary public hospital and included 120 women with CTS who were randomly allocated to manual therapy or surgery. The participants received 3 sessions of physical therapy, including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home. Primary outcome was pain intensity (mean and the worst pain). Secondary outcomes included functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale. Outcomes for this analysis were assessed at baseline, 1 year, and 4 years. The rate of surgical intervention received by each group was assessed throughout the study.
RESULTS: At 4 years, 97 (81%) women completed the study. Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1) and 4 years (mean pain: MD = 0.1, 95% CI = -0.2 to 0.4; worst pain: MD = 0.2, 95% CI = -0.8 to 1.2; function: MD = 0.1, 95% CI = -0.1 to 0.3; symptom severity: MD = 0.2, 95% CI = -0.2 to 0.6). Self-perceived improvement was also similar in both groups. No between-group differences (15% physical therapy vs 13% surgery) in surgery rate were observed during the 4 years.
CONCLUSIONS: In the long term, manual therapy, including desensitization maneuvers of the central nervous system, resulted in similar outcomes and similar surgery rates compared with surgery in women with CTS. Both interventions were combined with a tendon/nerve gliding exercise program at home.
IMPACT: This is the first study to our knowledge to report clinical outcomes and surgical rates during a 4-year follow-up and will inform decisions regarding surgical versus conservative management of CTS.
LAY SUMMARY: Women with CTS may receive similar benefit from a more conservative treatment-manual therapy-as they would from surgery.
This small, single-centre randomized study of manual therapy vs surgery for carpal tunnel syndrome showed equipoise in self-reported outcome measures. The manual therapy techniques are, I think, unknown to neurologists and neurosurgeons in North America. They are unconventional and unusual and seem to lack a pathophysiological rationale. The patients were carefully selected and probably excluded severe cases, where surgery would be expected to have a more likely positive outcome. I think more work needs to be done and should include more objective measures of outcome, e.g., repeat electrophysiological studies.
There is poor study evaluation and design. Perhaps the surgeons were not competent.
The methodology used in this RCT is not clear; consequently appraisal of the article's validity is not possible. Some issues not addressed properly are: 1. Why was a non-inferiority design chosen? How was the non-inferiority threshold chosen? 2. The BCTQ or Michigan Hand Questionnaire should have been used as the primary outcome and the sample size should be based on this and not the ad hoc numerical pain scale. 3. Was the study adequately powered? Most likely it was not.
This is a clinically important study which is quite informative regarding treatment options and their long-term efficacy in carpal tunnel syndrome. However, one may consider as a potential limitation the fact that all the outcomes of interest were based on the subjective report of the patients. No electrophysiological findings were compared at follow up.