Comparing surgery and physiotherapy for people with long-lasting tennis elbow: a feasibility study
| ISRCTN | ISRCTN96029840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96029840 |
| Integrated Research Application System (IRAS) | 351965 |
| Central Portfolio Management System (CPMS) | 65740 |
| National Institute for Health and Care Research (NIHR) | 170489 |
| Sponsor | University Hospitals of Leicester NHS Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 10/07/2026
- Registration date
- 20/07/2026
- Last edited
- 20/07/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Tennis elbow causes pain on the outside of the elbow and can make everyday activities difficult. Most people improve with physiotherapy, but some continue to have symptoms for many months. Surgery is sometimes offered, but we do not know whether surgery or physiotherapy works best for long-lasting tennis elbow. This study will test whether it is feasible to run a full trial comparing surgery with physiotherapy.
Who can participate?
Adults aged 18 years or over with tennis elbow affecting one arm, with symptoms lasting at least 6 months
What does the study involve?
Participants will be randomly allocated to either surgery or a structured physiotherapy programme. They will complete questionnaires at baseline and again at 3, 6, and 12 months. Some participants and clinicians will be invited to take part in an interview about their experiences.
What are the possible benefits and risks of participating?
The surgery offered as part of this study is used in routine NHS practice and the physiotherapy programme brings together elements of established practice; therefore, it is not anticipated that there are any ethical issues relating to our choice of treatments. Participants may benefit from receiving a structured treatment pathway. Risks relate mainly to surgery (such as infection or stiffness) or temporary discomfort during physiotherapy exercises. All risks are explained in the patient information sheet.
Where is the study run from?
The study is coordinated by the York Trials Unit at the University of York (UK)
When is the study starting and how long is it expected to run for?
August 2026 to October 2028
Who is funding the study?
The NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
York Trials Unit, ytu-sore-elbow-trial@york.ac.uk
Contact information
Principal investigator
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, Infirmary Square
Leicester
LE1 5WW
United Kingdom
 ORCID ID |
0000-0002-8686-2802 |
|---|---|
| harvinder.singh16@nhs.net |
Scientific
Derby Shoulder Unit, University Hospitals of Derby & Burton NHS Foundation Trust, Royal Derby Hospital, Uttoxeter Road
Derby
DE22 3NE
United Kingdom
| ORCID ID |
0000-0002-3203-506X |
|---|---|
| marcus.bateman@nhs.net |
Public
York Trials Unit, Department of Health Sciences, ARRC Building, University of York, Heslington
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0001-6902-0235 |
|---|---|
| Phone | +44 (0)1904 321522 |
| liz.cook@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Surgery or Rehabilitation for persistent tennis elbow: SORE Elbow Feasibility Trial |
| Study acronym | SORE Elbow |
| Study objectives | Primary objective: To assess the feasibility of conducting a full randomised controlled trial comparing surgical debridement with standardised physiotherapy rehabilitation for persistent tennis elbow Secondary objectives: 1. Determine recruitment rates, eligibility, approach, consent and randomisation numbers across sites 2. Assess adherence to physiotherapy and exercise programmes 3. Evaluate retention at 3, 6 and 12 months 4. Assess feasibility of collecting clinical, qualitative and health economic data 5. Explore patient and clinician experiences of trial participation and intervention acceptability |
| Ethics approval(s) |
Approved 14/07/2026, Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle, NE2 4NQ, United Kingdom; +44 (0)207 104 8014; tyneandwearsouth.rec@hra.nhs.uk), ref: 26/NE/0122 |
| Health condition(s) or problem(s) studied | Tennis elbow |
| Intervention | Participants are randomised in a 1:1 ratio between treatments, stratified by site and completed via REDCap centrally to ensure allocation concealment. Surgical arm: Open or arthroscopic debridement of the extensor origin for tennis elbow, performed under local, regional or general anaesthesia. Postoperative physiotherapy is not standardised and will be recorded pragmatically. Physiotherapy arm: A standardised rehabilitation programme based on the NIHR OPTimisE Trial, including education, progressive loading exercises, and lifestyle advice. Additional physiotherapy treatments will be recorded pragmatically. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Recruitment rate, defined as the proportion of eligible participants who go on to be randomised, measured using screening and enrolment data at the point of randomisation |
| Key secondary outcome measure(s) |
1. Recruitment metrics: screening, eligibility, approach, consent and randomisation numbers measured using site logs continuously throughout recruitment period |
| Completion date | 31/10/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Adults (aged ≥18 years) with unilateral tennis elbow characterised by ≥6 months of lateral elbow pain 2. Pain on palpation of the common extensor origin and pain on gripping 3. Positive Cozen’s, Mills’ or Maudsley’s test |
| Key exclusion criteria | 1. Suspected tumour or infection around the elbow 2. Recent significant elbow trauma or previous elbow surgery likely to affect outcomes 3. Cervical pain or radiculopathy that may be causing lateral elbow pain 4. Medial or anterior or posterior elbow pain in the same elbow, or pain in the contralateral elbow 5. Pregnancy 6. Comorbidities preventing surgical intervention |
| Date of first enrolment | 01/08/2026 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Infirmary Square
Leicester
LE1 5WW
England
Uttoxeter Road
Derby
DE22 3NE
England
Skipton Road
Steeton
Keighley
BD20 6TD
England
Gorleston
Great Yarmouth
NR31 6LA
England
Kayll Road
Sunderland
SR4 7TP
England
Holdforth Road
Hartlepool
TS24 9AH
England
Wigan Lane
Wigan
WN1 2NN
England
2-4 Waterloo PLACE
Edinburgh
City of Edinburgh
EH1 3EG
Scotland
Headley Way
Headington
Oxford
OX3 9DU
England
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon reasonable request after the publication of the study results from York Trials Unit (ytu-sore-elbow-trial@york.ac.uk). Requests will be reviewed by the Trial Management Group. Data will be anonymised before sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | 17/07/2026 | No | No |
Editorial Notes
10/07/2026: Study's existence confirmed by the NIHR.
