We developed a hand brace and studied its efficacy and tolerability in pati
ents with carpal tunnel syndrome (CTS). We randomized 83 subjects into a tr
eated group, which wore the hand brace at night for 4 weeks, and a control
group, which received no treatment. The primary efficacy measure was change
in the Boston Carpal Tunnel Questionnaire (BCTQ) score. Secondary measures
were Subjects' Global Impression of Change Questionnaire (SGlCQ), median d
istal motor latency, sensory conduction velocity and amplitude, and neuroph
ysiological class of severity. The treated group showed a reduction in BCTQ
symptomatic score (from 2.75 to 1.54 at 4 weeks; P < 0.001) and. functiona
l score (from 1.89 to 1.48; P < 0.001). There were no significant changes i
n the control subjects. SGlCQ documented improvement in all treated subject
s (P = 0.006). No significant difference was found in electrophysiological
measurements, but overall neurophysiological classification shifted to less
severe classes in the treated group (P < 0.05). Thus, the study demonstrat
es that this hand brace is highly efficient in relieving symptoms and funct
ional loss in CTS. (C) 2001 John Wiley & Sons, Inc.