24/82 Comparing surgery to conservative management for the treatment of tennis elbow with persistent symptoms commissioning brief

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

Is it feasible to conduct a randomised clinical trial to examine the effectiveness of surgery compared to conservative management for patients with tennis elbow with persistent symptoms for more than six months?

1. Patient group: Patients with tennis elbow with persistent symptoms for more than six months. 
2. Intervention: Surgery (applicants to define and justify type of surgery).
   Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
3. Comparator: Conservative management (applicants to define and justify type of conservative management, for example physiotherapy). Participants in the comparator group may subsequently have surgical treatment if needed.
4. Outcomes: Feasibility of conducting an RCT. Outcomes of interest for a full trial could include Patient Rated Tennis Elbow Evaluation (PRTEE), quality of life (EQ5D), ability to work/return to work.
5. Setting: Secondary care. 
6. Study design: A feasibility trial to determine whether it is possible to conduct a randomised clinical trial in this area and to establish key parameters of a potential future trial. As part of the feasibility trial applicants should investigate acceptability of randomisation to surgery or conservative management to patients (and healthcare professionals) and the feasibility of recruitment in a future trial (due to the potentially small number of patients who are still experiencing symptoms after six months). A decision on whether the HTA Programme will advertise for a substantive trial will be made when the feasibility study has completed. 

Rationale

Tennis elbow, clinically known as lateral epicondylitis, occurs when the muscles of the forearm, near the elbow joint, have been overused causing tears and leading to pain around the outside of the elbow. Tennis elbow is a common condition, and a small number of patients still suffer from symptoms 6 months after initial presentation. These persistent symptoms have a huge impact on pain, function and quality of life. Patients with persistent symptoms are currently offered surgery in the NHS without clear evidence of benefit as there is limited evidence for surgery over continued conservative management.

Little research has compared surgery to conservative management strategies, such as physiotherapy, and the need for large RCTs has been highlighted in the existing literature, by the Royal College of Surgeons, and in a recent elbow James Lind Alliance Priority Setting Partnership. Therefore, the HTA programme is interested in commissioning research to evaluate the feasibility of delivering a trial of surgery versus conservative management for patients in the NHS with persistent tennis elbow symptoms. As part of the feasibility trial applicants should investigate acceptability of randomisation to surgery or conservative management to patients (and healthcare professionals) and the feasibility of recruitment in a future trial (due to the potentially small number of patients who are still experiencing symptoms after 6 months).

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you would like to apply for this call, you can begin your application via the funding call page.

Your application must be submitted online no later than 1pm on 27 November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.

Guidance notes and supporting information for HTA Programme applications are available.

Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2025.

Applications received electronically after 1pm on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).

For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.

Should you have any queries, please email: htacommissioning@nihr.ac.uk.