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.