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
Clinicaltrials.gov Identifier
ISRCTN10290449
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
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.
Summary of Results:
Every year, in the UK, more than 20,000 people experience a life-changing injury and 85% of these will include a lower limb fracture. Of these patients, 60-85% will still experience problematic pain a year after their injury.The PROMOTE intervention was developed with patients and staff. The intervention was offered to patients within the first week post-initial operation for their lower limb injury. It included tools (e.g. reassurance, information, relaxation exercises) which aimed to reduce the likelihood of them developing a long-term problem with pain.
The current study:
(1) Examined if it was possible to run a full trial of PROMOTE compared to usual care for adults (16 years and over) who had experienced a lower-limb fracture.
(2) Interviewed patients and staff involved in the study to understand their experiences.Patients were recruited from four NHS sites and randomly allocated to either receive PROMOTE, which includes four face-to-face sessions with staff from the major trauma centre and access to the website or, usual care.
The study findings suggested it is possible to recruit patients to this study but staff could not deliver the face-to-face sessions and a large part of participants did not complete the 3-month questionnaires. Patients and staff made the following recommendations:
1. PROMOTE should be introduced later in the patient recovery journey
2. The intervention should not be focussed on pain but rather on general recovery support.
3. The next draft should be shorter and include fewer questionnaires.
4. Explore alternative delivery methods such as audio delivery i.e. a podcast
5. Ask patients with low social support and/or who are less economically privileged how we can make the intervention more appealing.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