JMIR Publications

ABSTRACT

Background:

Lateral epicondylitis (LE) is a condition that impairs daily activities due to pain exacerbated by wrist and hand movements. The ArmLock Sleeve is a novel, non-surgical intervention to stretch the wrist extensor muscles by maintaining the elbow in extension, forearm in pronation, and wrist and fingers in flexion.

Objective:

This study aimed to assess the effectiveness of sustained tension provided by the ArmLock Sleeve on pain and functional outcomes in adults with LE. This novel device supports the forearm by aligning the elbow in extension, the forearm in pronation, and the wrist in flexion, while keeping the metacarpophalangeal and interphalangeal joints of fingers II–V flexed.

Methods:

A within-subjects repeated measures design was used to assess outcomes at baseline, weeks 6, and 12. Nineteen participants wore the device at home for 30 minutes daily over 12 weeks. Outcome measures were administered by research assistants and included pain intensity, pain-free grip strength, pressure pain threshold, pain during resisted wrist extension, and composite extensibility of wrist and finger extensors. Repeated measures one-way ANOVA and Friedman tests were conducted (α = 0.05), followed by post hoc comparisons (α = 0.017, Bonferroni correction).

Results:

Significant improvements were observed in six of seven (85.7%) outcome variables, including increased muscle extensibility, enhanced grip strength, and reduced pain intensity. Participants reported decreased pain and functional disability in a self-reported questionnaire.

Conclusions:

Wearing the device daily for 12 weeks led to significant improvements in extensibility, grip strength, and pain reduction. Participants also reported decreased pain and disability. These results suggest that the ArmLock sleeve may support symptom relief and functional gains in individuals with LE. Larger, controlled studies are needed to confirm its effectiveness. Clinical Trial: ISRCTN13309889 https://www.isrctn.com/ISRCTN13309889