Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: Participants are randomised to one of two groups. Self‐learning manual group: Participants will be sent a manual with advice about chronic pain management and the potential implications and adverse effects of using opioids. It is a learning tool. These participants will also receive a relaxation CD and instructions on how to use it. Participants will be asked to practice and use the relaxation techniques in their own time. Participants will continue to receive their usual GP care whilst taking part in the I‐WOTCH study. Support programme group: Participants will be invited to a short course in addition to the above. The course is led by two facilitators and runs over 3 days. During the course participants will be encouraged to talk in a group with others who use opioids to manage chronic pain and think about their own lifestyle, experiences and behaviours. There will be an average of 12 people in a group. The course will include sessions about understanding pain, coping techniques, relaxation techniques, prescribing opioids for chronic pain, short and long term effects of opioids, pain control after opioids, managing reduction of opioids and more. Participants will attend the first and second group days and then meet on a separate day with the I‐WOTCH nurse for a one to one consultation. At this consultation the nurse and participant will create an opioid tapering plan. The third group day will follow the consultation. These activities happen over approximately 4 weeks. From weeks 5‐10 the participant has two telephone consultations with the nurse and then a further face to face consultation with the nurse to see how they are getting on with their tapering plan. All participants will be asked to complete a weekly diary up until 4 months from their randomisation into the study. At 4, 8 and 12 months all participants will be asked to complete a follow up questionnaire. CONDITION: Specialty: Primary Care, Primary sub‐specialty: Musculoskeletal disorders; UKCRC code/ Disease: Other/ General symptoms and signs ; Signs and Symptoms ; Chronic pain PRIMARY OUTCOME: Activities of daily living are measured using the Patient‐Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (8A)(PROMIS‐PI‐SF‐8A) at baseline, 4, 8 and 12 months. INCLUSION CRITERIA: 1. Provision of written informed consent 2. Aged 18 years old or above 3. Using opioids for chronic non‐malignant pain 4. Report using strong opioids for at least three months and on most days in the preceding month 5. Fluent in written and spoken English 6. Willingness for General Practitioner to be informed of participation SECONDARY OUTCOME: 1. Self‐reported data on opioid use will be collected using a postal questionnaire at baseline, 4, 8 and 12 months ; 2. Pain severity is measured using the PROMIS Scale V1.0 – Pain Intensity Short Form 3a at baseline, 4, 8 and 12 months; 3. Symptoms are measured using the Severity of Opioid Withdrawal (Symptoms): Short Opiate Withdrawal Scale (ShOWS) at baseline, 4, 8, 12 months and weekly from randomisation to 4 months; 4. Health related quality of life is measured using the SF12 V2.0 and EQ5D‐5L at baseline, 4, 8 and 12 months; 5. Sleep quality is measured using the Pittsburgh Sleep Quality Index at baseline, 4, 8 and 12 months; 6. Emotional wellbeing is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 4, 8 and 12 months; 7. Self‐efficacy is measured using the Pain Self Efficacy Questionnaire (PSEQ) at baseline, 4, 8 and 12 months; 8. Resource use is measured using a combination of routinely collected NHS data, GP data, HES data and patient self‐reported data at 4, 8 and 12 months;
Epistemonikos ID: bd1c57b3e335abe2ec2ff508bea410fb19d266be
First added on: Aug 24, 2024