Prospective randomized controlled trial in the treatment of lateral epicondylitis with a new dynamic wrist orthosis

Abstract

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 + 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 + O: 6.5-3.7 [p = .001]; PT: 4.7-4.1 [p = .468]), albeit it was only significant for the PT + O group. At 12 months, reduction was significant in both groups (PT + O: 1.1 [p = .000]; PT: 1.3 [p = .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 = .001] after 12 weeks for the PT + O group and from 8.1 to 3.8 [p = .000] in the PT group, as well as after 12 months in the PT + O group to 0 [p = .000] and in the PT group to 2.0 [p = .000]. The PRTEE improved in both groups after 12 weeks (PT + O: 52.8--31.3 [p = .002]; PT: 48.6-37.6 [p = .185]) and 12 months (PT + O: 16.15 [p = .000]; PT: 16.6 [p = .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.

Figures

Fig. 1

Novel dynamic wrist orthosis that unloads wrist extensors

Fig. 2

Boxplot of outcome parameter—pain on the VAS: baseline, 12 weeks and 12-month follow-up, left: orthosis plus eccentric strengthening exercises, right: eccentric strengthening exercises alone. (PT + O: 6.5–3.7 [p = .001] to 1.1 [p = .000]; PT: 4.7–4.1 [p = .468] to 1.3 [p = .000])

Fig. 3

Boxplot of outcome parameter—painless maximum hand strength in kg: baseline, 12 weeks and 12-month follow-up, left: orthosis plus eccentric strengthening exercises, right: eccentric strengthening exercises alone. {PT + O: 9.9 (SD: 12.1) to 18.9 (SD: 14) [p = .009] to 25.3 (SD: 9.3) [p = .028]; PT: 14.8 (SD: 17.5) to 19.9 (SD: 17.1) [p = .031] to 32.2 (SD: 15.9) [p = .013]}

Fig. 4

Boxplot of outcome parameter—PRTEE: baseline, 12 weeks and 12-month follow-up, left: orthosis plus eccentric strengthening exercises, right: eccentric strengthening exercises alone. {PT + O: 52.8 (SD: 16.0) to 31.3 (SD: 8.2) [p = .002] to 16.15 (SD: 16.1) [p = .000]; PT: 48.6 (SD: 19.7) to 37.6 (SD: 24.1) [p = .185] to 16.6 (SD: 16.1) [p = .000]}