PROMOTE
Research type
Research Study
Full title
Feasibility of a pain management intervention to improve recovery after major trauma: the PROMOTE study
IRAS ID
318428
Contact name
David Keene
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
‘Major Trauma’ occurs when a person sustains serious injuries to one part of the body or injuries to several parts of the body at the same time. It is often caused by road traffic accidents or falls from a height and most people have injuries to their legs.
Pain immediately after a major injury is common and can last many months. Some people also experience pain after the injury has healed. People experiencing long-term pain after a leg injury are more likely to become more disabled and have poorer quality of life than people who do not have pain. Researchers have found that the way people think, feel and act after injury is related to how well they recover.
The purpose of this study is to assess the feasibility of delivering a new treatment that aims to improve the management of pain after a major injury of the leg.Participants will be 16 years old or older and have suffered from a major trauma injury affecting their leg which required surgery. Participants will be recruited from five major trauma centres across the UK and will be randomly allocated to one of the two study groups, i.e. usual care (as per hospital´s usual treatment) or PROMOTE treatment (usual care plus four rehabilitation sessions and access to the pain rehabilitation training materials via the study website). Participants will complete online questionnaires about their pain, ability to perform certain activities, complications and use of pain medication at the recruitment time-point and 6 weeks and 3 months later.
Patient interviews and staff focus groups will also be carried out, assessing the participant and the staff’s experience of the PROMOTE intervention and trial.
This is a feasibility study, and if successful will guide the development of a larger trial.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0305
Date of REC Opinion
19 Sep 2023
REC opinion
Favourable Opinion