ABSTRACT
OBJECTIVE: To examine, in a randomized, controlled, single blinded trial, the efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome (CTS). METHODS: We randomized 120 patients with CTS into a group wearing the soft hand brace MANU and into another group wearing the wrist splint CAMP TIELLE at night for 3 months. We re-evaluated the patients after 3 (T1) and 9 months (T2). The primary efficacy measures were changes in scores of Boston Carpal Tunnel Questionnaire (BCTQ) and in Visual Analogical Scale (VAS) for pain and paresthesias. RESULTS: At T1, both groups showed a significant reduction in symptomatic and functional BCTQ (T0-T1 differences: MANU BCTQ sympt: 0.88 (0.68-1.08), funct: 0.45 (0.19-0.72); TIELLE BCTQ sympt: 0.78 (0.55-1.01), funct: 0.41 (0.22-0.59). At T2, a less evident benefit on symptoms persisted in both groups, except for pain VAS score that was significantly reduced only in the CAMP TIELLE group. No significant functional benefits persisted in either group. There were no differences in BCTQ and VAS scores between the two groups at T1 and T2 compared with that at baseline. CONCLUSIONS: A 3-month treatment with either the hand brace or the wrist splint induces a symptomatic and functional benefit in patients with CTS.
