AN INNOVATIVE HAND BRACE FOR CARPAL TUNNEL SYNDROME.  A RANDOMIZED CONTROLLED TRIAL

G.Manente, MD(1), F. Torrieri, MD(1), F.Di Biasio, MD(1), T. Staniscia, MD(2), F. Romano, MD, MSc(2), A. Uncini, MD(1)*

1 : Center for Neuromuscular Disease University " G. d'Annunzio," Chieti, Italy

2 : Department of Biomedical Sciences University "G. d'Annunzio," Chieti, Italy

Funded by: Italian Ministry for Scientific and Technological Research

We developed a hand brace and studied its efficacy and tolerability in patients with carpal tunnel syndrome (CTS). We randomised 83 subjects into a treated 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 Carpa Tunnel Questionnaire (BCTQ) score. Secondary measures were Subjects1 Global Impression of Change Questionnaire (SGICQ), median distal motor latency, sensory conduction velocity and amplitude, and neurophysiological 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 functional score (from 1.89 to 1.48; P <0.001).

There were no significant changes in the control subjects. SCICQ documented improvement in all treated subjects (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 demonstrates that this hand brace is highly efficient in relieving symptoms and functional loss in CTS.

© 2001 John Wiley & Sons, Inc. Muscle Nerve 24: 1020-1025, 2001-07-19

For further studies...   

Although the Manu device is intended for home use, it should be used under the guidance of a Healthcare Professional.