Specialty: Primary Care, Primary sub-specialty: Musculoskeletal disorders
Conditions
Interventions
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 e
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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 3 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
Exclusion criteria
Exclusion criteria: 1. Regular use of injected opioid drugs 2. Report chronic headache as the dominant painful disorder 3. Serious mental health problems that preclude participation in a group intervention 4. Using opioids for malignant pain 5. Unable to attend group sessions 6. Previous entry or randomisation in the present trial. 7. Participation in a clinical trial of an investigational medicinal product in the last 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed