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Open Access Highly Accessed Study protocol

Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: A protocol for a randomised, placebo-controlled study

Morten Olaussen13*, Øystein Holmedal23, Morten Lindbæk3 and Søren Brage3

Author Affiliations

1 Grålum Medical Center, Tuneveien 96, NO-1712 Grålum, Norway

2 Hafslundsøy Medical Center, Helgebyveien 2, NO-1734 Hafslundsøy, Norway

3 Institute of General Practice and Community Medicine, University of Oslo, PO Box 1130 Blindern, NO-0318 Oslo, Norway

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BMC Musculoskeletal Disorders 2009, 10:152  doi:10.1186/1471-2474-10-152

Published: 4 December 2009

Abstract

Background

Lateral epicondylitis is a painful condition responsible for loss of function and sick leave for long periods of time. In many countries, the treatment guidelines recommend a wait-and-see policy, reflecting that no conclusions on the best treatment can be drawn from the available research, published studies and meta-analyses.

Methods/Design

Randomized double blind controlled clinical trial in a primary care setting. While earlier trials have either compared corticosteroid injections to physical therapy or to naproxen orally, we will compare the clinical effect of physiotherapy alone or physiotherapy combined with corticosteroid injection in the initial treatment of acute tennis elbow. Patients seeing their general practitioner with lateral elbow pain of recent onset will be randomised to one of three interventions: 1: physiotherapy, corticosteroid injection and naproxen or 2: physiotherapy, placebo injection and naproxen or 3: wait and see treatment with naproxen alone. Treatment and assessments are done by two different doctors, and the contents of the injection is unknown to both the treating doctor and patient. The primary outcome measure is the patient's evaluation of improvement after 6, 12, 26 and 52 weeks. Secondary outcome measures are pain, function and severity of main complaint, pain-free grip strength, maximal grip strength, pressure-pain threshold, the patient's satisfaction with the treatment and duration of sick leave.

Conclusion

This article describes a randomized, double blind, controlled clinical trial with a one year follow up to investigate the effects of adding steroid injections to physiotherapy in acute lateral epicondylitis.

Trial Registration

ClinicalTrials.gov Identifier: NCT00826462