Funded by: Physiotherapy Research Foundation
Project lead: Dr Shea Palmer
Project team: Dr Shea Palmer (UWE), Dr Fiona Cramp (UWE), Prof Mark Johnson (LeedsMet), Melissa Domaille (UBHT)
Background: Systematic reviews suggest that both TENS and exercise reduce OA knee pain. TENS has been advocated as an adjunct to other treatments, although the combined effects with exercise have yet to be clearly demonstrated.
Objective: To determine the effectiveness of a 6-week TENS and exercise regime in knee OA using a randomised sham-controlled clinical trial (RCT).
Design: A 3 arm parallel group design. Participants will receive either: 1) TENS and exercise; 2) sham TENS and exercise; or 3) exercise alone. A focus group of service users will directly shape the study protocol.
Recruitment: Patients referred to physiotherapy at United Bristol Healthcare Trust (UBHT) with a diagnosis of OA knee will be invited to participate. Following consent, baseline recordings will be taken and participants randomly assigned to groups. 87 participants will be recruited to each group (total n=261).
Treatment: All participants will receive an evidence-based 6-week group education and exercise programme. Participants receiving active TENS will select parameters that generate a “strong but comfortable” electrical paraesthesia and will use the device as much as needed. Dummy devices will administer sham TENS.
Outcome Measures: Blinded assessment will take place at baseline, 3, 6, 12 and 24 weeks. Primary outcomes will include pain, stiffness, function, extensor torque, self efficacy and patient global assessment of change. Secondary outcomes will be logged TENS usage time and self-reported exercise adherence.
Data Analysis: Primary data analysis will be on an intention to treat basis, although exercise adherence and TENS usage data will also be included as covariates.
Duration: Jul 2007-Jun 2009
For further information contact Shea Palmer:
+44 (0)117 32 88919