Title: Feasibility of a pain management intervention to improve recovery after major trauma: the PROMOTE study
Funder: Department of Health and Social Care

Abstract: Background In the UK each year at least 20,000 people are affected by major trauma. After trauma the majority (63%) have moderately severe pain related to their injuries at one-year. Chronic post-traumatic lower limb pain is associated with substantial ongoing functional limitations, delayed return to work, and lower quality of life. There are few non-pharmacological interventions aimed at managing pain early after major trauma to reduce its longer-term impact on disability and quality of life. With patient and public involvement representatives and clinical stakeholders we have developed the PROMOTE intervention. The intervention uses psychological techniques early in recovery, targeting modifiable psychological factors (pain self-efficacy, pain-catastrophizing and fear-avoidance) to facilitate engagement in meaningful activity and recovery goals even when pain persists. Aim Determine feasibility of a definitive multicentre Randomised Clinical Trial (RCT) of a novel intervention using psychological techniques to help people self-manage their pain after a major lower limb injury. Design A randomised multicentre feasibility study with an embedded qualitative study Methods Trial material production: Production of high quality materials (provider training, web-application and workbook) with patient and public involvement and clinical stakeholders to enable use of the PROMOTE intervention across the NHS. Feasibility RCT Setting: Five NHS hospital trauma departments. Target population: Sixty patients aged 16 years and over with an acute major lower limb fracture. Patients with clinically significant brain or spinal cord injury will be excluded. Randomisation: Using a web-based system, 1:1 stratified by centre. Intervention: Uses Cognitive Behavioural Therapy techniques to target key modifiable psychological factors (pain self-efficacy, pain-catastrophising and fear-avoidance). Two face-to-face contact sessions with a PROMOTE trained health professional will take place during in-patient care. This will provide i) acknowledgment of the consequences of injury and impact on future pain and disability, and ii) an overview of the paper based workbook/materials and web-based support. The mobile-friendly website will include brief video sessions, simple behavioural and cognitive exercises (including models of pain and its management, relaxation techniques, and activity scheduling). Participants will be contacted by phone/videocall at 2- and 6-weeks post-discharge to support engagement. Control: Usual care Embedded qualitative study: Semi-structured interviews/focus groups with patients and health professional focus groups to assess acceptability, feasibility and barriers and facilitators. Data collection Feasibility data: recruitment rate of those eligible, completion of study sessions and use of intervention materials, quality assurance checks, retention, patient and health professional experience. Follow-up: 6 weeks and 3 months. Outcome measures: Mobility and function, health-related quality of life, pain severity and interference, distress, pain catastrophizing, self-efficacy, fear avoidance, adverse events. Timelines for delivery Months 0-6 trial material production, approvals, project and site set-up, 7-12 recruitment, 8-18 focus group/interviews, 16-19 analysis, 18-20 intervention and trial design refinement, 21 reporting and further funding application. Anticipated Impact and Dissemination If feasibility is shown, a funding application for the definitive trial will be made to NIHR HTA. Findings will be published and shared at conferences. Our PPI co-applicants will lead development of lay summaries and in developing our strategy for reaching patient networks.

Lay abstract: Aim of the research To assess the feasibility of a new psychological treatment that aims to help people self-manage their pain after a major injury to their leg. Background Severe pain immediately after a major injury is anticipated. However, after the injury has healed, six out of every ten people experience pain for years afterwards. Our research showed people experiencing long-term pain after a leg injury are likely to become more disabled and have poorer quality of life than people who do not have pain. Researchers have found if a person recovering from injury holds certain beliefs and engages in certain behaviours they are more likely to develop long-term disability. For example, a person who believes they can perform activities whilst in pain will use less medication and be less disabled than those who believe they are unable to undertake activities. Design and methods Cognitive Behavioural Therapy helps people identify thoughts, feelings and actions that improve health. It has proved useful in long-term pain, helping with problems such as being fearful of pain. We would like to see if it is useful just after major injury as a preventative treatment. The aim is to reduce the impact of pain on disability and improve quality of life. The treatment focuses on improving patient s confidence to manage pain and return to meaningful activities even when pain persists. It involves strategies such as planning daily activities, setting goals and relaxation exercises. Trained rehabilitation team members will introduce patients to the treatment prior to hospital discharge and sessions will continue afterwards. The proposed research will: enable patient representatives and health professionals to work together to produce high-quality materials to support treatment delivery across the NHS (training, website, videos and workbook). test the treatment by recruiting sixty patients after a major leg injury from five hospitals to a feasibility study to assess how it works in practice. Participants will be allocated at random so half have the new treatment and others their usual care. assess feasibility of: patient engagement with the study, treatment and questionnaires quality treatment delivery acceptability to patients and clinical staff questionnaire completion gain feedback from participants and health professionals using interviews. refine the treatment prior to evaluation in a randomised controlled trial. The study team includes patient representatives, health researchers and clinical experts in psychology, pain, rehabilitation and surgery. Patient and Public Involvement Six PPI representatives helped to shape the proposal, three participated in interviews. PPI representatives will help produce the treatment materials and be involved throughout the study. Dissemination Findings will be shared in free-to-access scientific journals and at conferences. Our PPI team member will develop lay summaries and be actively involved in reaching patient networks.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INJURIES AND ACCIDENTS