Authors' objectives: Nearly eight million people in the UK have long-term painful disorders such as low back pain, neck pain, arthritis, fibromyalgia, neuralgia (nerve pain), and pain after surgery. This pain has a major impact on daily living and wellbeing. A substantial minority of those affected are using long-term strong opioid drugs. These include tablets such as tramadol or oxycodone and long-acting patches such as fentanyl or buprenorphine. Morphine is sometimes prescribed. Although opioids can be very effective in the short term they have little effect on long-term pain. In the long term they may lose their pain relieving effects completely; or even cause a paradoxical increase in pain There are concerns about the adverse health impact of strong opioids. Around half of people taking opioids have undesirable side effects; including nausea, vomiting, constipation, sleep disturbance, unusual drowsiness, & reduced mental capacity. In the older population, side effects mean opioid drugs increase both number of broken bones and number of deaths. Over recent years there have been substantial increases in the amount of these drugs prescribed in the UK. There is a need for a proven intervention, targeting opioid use that helps people with long standing pain to get on with their lives without opioid drugs. Participants and recruitment 468 people living with chronic pain treated with strong opioids will be recruited from around 100 general practices to a randomised controlled trial testing the effect of adding a supportive self-management and information/advice about coming off opioid drugs (the I-WOTCH intervention) to best practice paper/on-line advice. Intervention In a previous large study of supportive self-management for people living with chronic pain we found long-term benefits on depression and anxiety. This intervention did not target opioid use. We are adapting this to include opioid specific elements such as education on side effects and providing additional support, to promote withdrawal from opioid drugs. Over a ten week period there will be three days attending a self-management group plus two face to face and two telephone consultations with a specially trained pain nurse. Control Intervention An adaption of My Opioid Manager , an, electronic/paper guide, to opioid use developed in Canada will be used with a relaxation CD. We will work with patient partners and GPs to ensure it is relevant to the UK context. Outcome Measures Participants will be asked to complete follow-up postal questionnaires four, eight and twelve months after joining the study. Our main outcomes will be how well people can get on with normal activities (e.g. work, family, & social life) and opioid use. To decide if the I-WOTCH intervention represents good value for money we will also collect data on all the NHS Costs associated with their care. Some of the benefits from stopping the use of strong opioid drugs may not be apparent within one year of follow-up; we will therefore estimate the long-term benefits of the I-WOTCH intervention using information from within this trial and what is already known about the effects of opioids on these important outcome. In a parallel interview study we will explore, staff experiences of delivering the interventions, and patients perceptions and experiences of participating in the intervention. This will help us to understand how the intervention might work and improve how we deliver the intervention in the future.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/1422404

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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