BACKGROUND: In the treatment of lateral epicondylitis (LE), the role of a new dynamic wrist orthosis is unclear. PATIENTS AND METHODS: Patients suffering from a LE longer than 3 months were multicentrically and prospectively randomized into a physiotherapeutic group (PT group) and in a physiotherapy group plus wrist orthosis (PT plus O group). Physiotherapy consisted of daily eccentric strengthening exercises under initial professional supervision. Inclusion criteria were a Placzek score greater than 4. Exclusion criteria were previous surgery, rheumatic arthritis, elbow instability, radicular symptoms, higher-grade extensor tendon rupture, or cervical osteoarthritis. The clinical evaluation was performed after 12 weeks and 12 months. The Patient-Rated Tennis Elbow Evaluation (PRTEE) scale, Placzek Score, the pain rating (VAS), range of motion and the Subjective Elbow Score were evaluated. RESULTS: Of the initially 61 patients, 31 were followed up after 12 weeks and 22 after 12 months. Twenty-nine patients (43%) were male, the mean age was 46, and 44 patients (66%) had the right elbow involved. At 12 weeks, there was a pain reduction on the VAS in both groups (PT plus O 6.5 to 3.7 (p = 0.001); PT 4.7 to 4.1 (p = 0.468)), albeit it was only significant for the PT plus O group. At 12 months, reduction was significant in both groups (PT plus O 1.1 (p = 0.000); PT 1.3 (p = 0.000)). The painless maximum hand strength in kg improved in both groups significant after 3 and 12 months. The Placzek score was reduced from 8.25 to 3.5 (p = 0.001) after 12 weeks for the PT plus O group and from 8.1 to 3.8 (p = 0.000) in the PT group, as well as after 12 months in the PT plus O group to 0 (p = 0.000) and in the PT group to 2.0 (p = 0.000). The PRTEE improved in both groups after 12 weeks (PT plus O 52.8 to -31.3 (p = 0.002); PT 48.6 to 37.6 (p = 0.185)) and 12 months (PT plus O 16.15 (p = 0.000); PT 16.6 (p = 0.000)), although the reduction at 12 weeks was not significant for the PT group. CONCLUSION: The elbow orthosis appears to accelerate the healing process with respect to the PRTEE and pain on the VAS (12 weeks follow-up), although there is an adjustment after 12 months in both groups and a significant improvement of symptoms is achieved in all endpoints.

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