Evaluation of Clemastine's Effects on Clinical and Electrodiagnostic Parameters in Individuals With CTS: A Preliminary Placebo-Controlled Double-Blind RCT.

OBJECTIVE

To evaluate the efficacy of clemastine in improving clinical and electrophysiological outcomes in patients with carpal tunnel syndrome (CTS) when combined with standard splint therapy.

DESIGN

A double-blind, randomized, placebo-controlled trial with follow-up assessments at 1 and 3 months.

SETTING

A physical medicine and rehabilitation outpatient clinic.

PARTICIPANTS

Adult patients (N=27) (mean age=46.4y; sex ratio, 29.2% men and 70.8% women), enrolled with electrodiagnostically confirmed mild to moderate CTS, were randomized into clemastine (n=14) and placebo (n=13) groups.

INTERVENTIONS: The treatment group received 1 mg oral clemastine nightly plus a wrist splint, while the control group received a placebo plus an identical wrist splint, with both interventions maintained for 3 months.

MAIN OUTCOME MEASURES: Primary endpoints included Boston Carpal Tunnel Questionnaire Symptom Severity (BQ-SS) and Functional Status (BQ-FS) scores, nerve conduction study parameters (median nerve sensory and motor distal latency), and ultrasonographic median nerve cross-sectional area.

RESULTS

The case group showed a significant difference in follow-up mean BQ-FS and BQ-SS scores (ANOVA, p<.01) at 1 month and 3 months compared with the control. No significant differences were found in the nerve conduction study or ultrasonographic cross-sectional area between groups.

CONCLUSIONS

Clemastine, combined with wrist splinting, may provide further clinical benefits in patients with CTS, particularly in improving BQ-SS and BQ-FS outcomes. Further research is necessary to confirm these findings and explore appropriate dosing options.