OPTimisE - Pilot & Feasibility RCT v1.0
Research type
Research Study
Full title
Optimising Physiotherapy for people with Tennis Elbow – a mixed methods pilot & feasibility randomised controlled trial.
IRAS ID
297637
Contact name
Marcus Bateman
Contact email
Sponsor organisation
University Hospitals of Derby & Burton NHS Foundation Trust
ISRCTN Number
ISRCTN64444585
Duration of Study in the UK
2 years, 6 months, 29 days
Research summary
Physiotherapy is commonly provided by the NHS for people with Tennis Elbow. The type of treatment given by physiotherapists varies widely, however, with many treatment techniques lacking evidence of effectiveness. We have developed an optimised physiotherapy treatment package based upon a combination of best research evidence and expert opinions of specialist physiotherapists, NHS physiotherapy service managers and patients that we hope will improve the outcomes for people with Tennis Elbow. The aim of this study is to test the feasibility of delivering this new treatment package in the NHS and determine whether a large-scale research trial is justified to assess its effectiveness.
This study will be based at three large NHS physiotherapy clinics in the UK and will recruit participants for up to a year, or to a maximum of 50 people. Adults with Tennis Elbow would be eligible to participate. Eligible people will be identified from NHS physiotherapy referrals to each clinic and by searching the records at local GP practices for people with a recent diagnosis of Tennis Elbow. If willing to participate, people will be randomised to receive the new optimised physiotherapy treatment package or the usual physiotherapy treatment that they would have received normally.
Participants will complete questionnaires prior to treatment and for up to six months after starting, to measure the effect of treatment. A selection of patients and physiotherapists will be interviewed regarding the treatment package, research procedures, information provided to patients and training provided to physiotherapists to assess if a large-scale trial is justified and if so, how the processes could be improved. Other measures, such as the amount of people participating, the number of people completing treatment and how successfully the optimised treatment was delivered, will also be used to assess whether this is justified.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0121
Date of REC Opinion
22 Jun 2021
REC opinion
Further Information Favourable Opinion