Improving the Wellbeing of people with Opioid Treated CHronic pain – The I-WOTCH Study
Recent debates have highlighted the risk of the UK facing a prescription opioid epidemic. Living with chronic pain can have a major impact on wellbeing, quality of life and productivity. Despite limited data supporting the effectiveness of long-term use, prescription data from the UK show substantial increases in the use of opioids for non-cancer pain with a 466% increase in the number of strong opioid users between 2000 and 2010. However, adverse effects including sedation, decreased concentration and memory, changes in mood and constipation, often outweigh any treatment benefits. Despite growing recognition of the importance of seeking to reduce long-term opioid use, formal UK guidelines for opioid reduction do not exist and there is limited support for people wishing to reduce their intake.
I-WOTCH study will evaluate the effectiveness and cost effectiveness of a patient-centred multicomponent self-management intervention for people living with chronic non-malignant pain, that targets withdrawal of strong opioids on activities of daily living and opioid related adverse events. A definitive multi-centre randomised controlled trial recruiting 468 participants from primary care, pain clinics and pharmacies. Those randomised to the I-WOTCH intervention will receive a three day group facilitated course led by a trained nurse and a lay person with chronic pain and experience of opioid withdrawal/tapering. In addition, participants will also receive one-to one sessions (face to face and telephone with the trained nurse) to develop a tapering plan. Participants will also receive a copy of (My Opioid Manager (anglicised); a self-help guide for people using opioid drugs for chronic pain)). Those in the control intervention will receive (My Opioid Manager (anglicised) and a relaxation CD only.
The primary outcome measure is ‘activities of daily living’ measured by the Patient-Reported Outcomes Measurement Information System, Pain Interference Short Form (8A)(PROMIS-PI-SF-8A). The main secondary outcome is opioid use defined as mean difference in morphine equivalent dose in the four weeks prior to one-year follow-up expressed as mg of morphine per day. Other secondary outcomes include: adverse events, health related quality of life, sleep quality, emotional wellbeing, self-efficacy and resource use. Data will be collected at base line, four, eight and twelve months. We will present data from the pilot phase of the trial.
The findings from this trial will inform clinical practice on the identification and management of patients with non-malignant chronic pain, seeking to support a reduction in/withdrawal from opioid use.