Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)

Abstract

Objective: To investigate the effectiveness of supplementing information and advice on analgesia and exercise from a general practitioner with transcutaneous electrical nerve stimulation (TENS) as a non-drug form of analgesia to reduce pain intensity in patients with tennis elbow.

Design: Pragmatic randomised controlled trial in primary care.

Setting and: 38 general practices in the West Midlands, UK.

Participants: 241 adults consulting with a first or new (no consultation in previous six months) clinical diagnosis of tennis elbow.

Interventions: Participants were randomly allocated to either primary care management alone, consisting of a consultation with a general practitioner followed by information and advice on exercises, or primary care management plus TENS to be used once a day for 45 minutes over six weeks (or until symptom resolution) for pain relief.

Outcome measures: The primary outcome was self reported intensity of elbow pain (0-10 rating scale) at six weeks. Primary and secondary outcomes were measured at baseline and at six weeks, six months, and 12 months by postal questionnaire. Analysis was by intention to treat.

Results: 121 participants were randomised to primary care management plus TENS and 120 to primary care management only (first episode, n=197 (82%); duration <1-3 months, n=138 (57%)). Adherence to exercise and TENS recommendations reported at six weeks was low; only 42 participants in the primary care management plus TENS group met a priori defined adherence criteria. Both intervention groups showed large improvements in pain and secondary outcomes, especially during the first six weeks of follow-up. However, no clinically or statistically significant differences were seen between groups at any follow-up timepoint. At the primary endpoint (six weeks), the between group difference in improvement of pain was -0.33 (95% confidence interval -0.96 to 0.31; P=0.31) in favour of the primary care management only group, with adjustment for age, sex, and baseline pain score.

Conclusions: This trial does not provide evidence for additional benefit of TENS as an adjunct to primary care management of tennis elbow. Poor adherence to interventions is evidence of the challenges of implementing self management treatment strategies in primary care.

Trial registration: Current Controlled Trials ISRCTN87141084.

Fig 1 Flow chart showing recruitment and retention of participants. ITT=intention to treat. *One participant in primary care management (PCM) plus transcutaneous electrical nerve stimulation (TENS) arm and one participant in PCM only arm were withdrawn from study owing to subsequent ineligibility (both patients were deemed not to have tennis elbow). †Reasons for participants’ withdrawal from follow-up assessment: PCM plus TENS arm—two did not want to continue; PCM arm—five did not want to continue, two were better and did not want to continue, one had a family bereavement, one expressed personal reasons, and one did not give a reason

Fig 2 Course of pain intensity (unadjusted mean (95% CI) scores, 0-10 numerical rating scale) for two intervention groups during trial. PCM=primary care management; TENS=transcutaneous electrical nerve stimulation