Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5160 (Published 02 September 2013) Cite this as: BMJ 2013;347:f5160
- Linda S Chesterton, senior lecturer 1,
- A Martyn Lewis, reader in biostatistics1,
- Julius Sim, professor of health care research12,
- Christian D Mallen, professor of general practice research1,
- Elizabeth E Mason, programme manager1,
- Elaine M Hay, professor in community rheumatology1,
- Daniëlle A van der Windt, professor in primary care epidemiology1
- 1Arthritis Research UK Primary Care Centre, Keele University, Keele, Staffordshire, ST5 5BG, UK
- 2School of Health and Rehabilitation, Keele University, UK
- Correspondence to: L S Chesterton
- Accepted 11 August 2013
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.
We thank all the general practitioners and patients who contributed to this trial, as well as the members of the Trial Steering Committee and the Data Monitoring Committee.
Contributors: All authors contributed to the study concept and design. LSC, AML, EEM, and DAvdW were involved in acquisition of data. LSC, AML, JS, EMH, and DAvdW analysed and interpreted the data. All authors were involved in drafting or writing the manuscript and critically revising it for important intellectual content. DAvdW and EMH supervised the study. AML is the guarantor.
Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under the Research for Patient Benefit Programme (grant reference No PB-PG-0407-13189). CDM is supported by an Arthritis Research UK clinician scientist award. EMH is an NIHR senior investigator. The Institute for Primary Care and Health Sciences at Keele has been awarded the Arthritis Research UK Primary Care Centre of Excellence (grant No 20202). The NIHR had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; or preparation and review of the manuscript. The conclusions and views expressed in this article are those of the authors and not necessarily those of the NHS, NIHR, or Department of Health.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: EMH, DAvdW, LSC, AML, and JS had support from an NIHR Research for Patient Benefit grant, and EHM had support from the grant for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work or activities of this type.
Ethical approval: Ethical approval was obtained from the South Staffordshire Local Research Ethics Committee in May 2009 (reference No 09/H1203/31). All participants gave written informed consent.
Data sharing: Participants did not give informed consent for data sharing, but the data are anonymised and the risk of identification is low. Data from the trial may be available from the corresponding author atsubject to agreement about the use of the data.
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