Background/Purpose: Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and has been associated with systemic conditions such as rheumatoid arthritis, hypothyroidism, and obesity, as well as occupational tasks involving repetitive manual activities. The most common treatments for CTS have several drawbacks, such as invasiveness (surgery), lack of long-term efficacy (corticosteroid injections), or low compliance (braces). To overcome these shortcomings, an unobtrusive and non-invasive device was developed to treat CTS by relieving pressure on the median nerve. This carpal tunnel tissue manipulation device (CTMD) is attached to the volar aspect of the wrist and applies a consistent level of tension to the underlying tissue. A pilot clinical trial was performed to investigate the feasibility, safety and efficacy of the CTMD to relieve symptoms of and potentially treat CTS.

Methods: Subjects with mild to severe unilateral or bilateral CTS, confirmed using electrodiagnostic testing and AANEM criteria, were enrolled into the study. Subjects with concomitant ulnar or radial neuropathies, diabetes, thyroid disease, or connective tissue diseases were excluded. The CTMD was worn on the affected wrist(s) for 8-10 hours daily for 28 days, followed by 8 weeks of no CTS treatment. The primary outcome measure was the Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The BCTQ was administered at 0, 2, and 4 weeks into treatment, and 8 weeks post-treatment. Data for bilateral subjects were evaluated only for the wrist with higher CTS severity and higher BCTQ score.

Results: Eleven (11) subjects were enrolled: mean age 51.4 years (±11.1), 64% female, 7 treated for unilateral CTS and 4 for bilateral CTS. Subjects’ average SSS score reduced from baseline by 0.63 ± 0.56 points at 2 weeks and by 0.59 ± 0.68 points at 4 weeks (p<0.05). Subjects’ scores continued to improve 8 weeks post-treatment, resulting in an overall improvement in SSS of 0.79 ± 0.74 points (p<0.01). Although a history of connective tissue disorders was an exclusion criteria, it was later found that two subjects had or possibly had arthritis. One subject had wrist arthritis and unilateral CTS but showed improvement of 0.91 points 8 weeks post-treatment. In contrast, the other subject had unconfirmed RA and bilateral CTS and experienced a 0.46 point degradation 8-weeks post-treatment. Unilateral CTS subjects’ average SSS score improved more than bilateral subjects at each timepoint and most significantly at 8 weeks post-treatment (1.2 ± 0.5 points vs. 0.09 ± 0.41 points).

Conclusion: At least 4 weeks of daily wear of the CTMD improved severity of CTS symptoms in patients with unilateral CTS. These results suggest that the CTMD may have a lasting effect up to 8 weeks post-treatment. Bilateral CTS patients may respond differently to treatment than unilateral CTS patients. An extended, randomized, placebo-controlled study is proposed to investigate long-term effects.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pilot-clinical-study-of-a-novel-unobtrusive-carpal-tunnel-tissue-manipulation-device-in-reducing-symptoms-of-carpal-tunnel-syndrome/