Improving the wellbeing of people living with opioid treated chronic pai

Not Applicable

Completed

• Conditions: UKCRC code/ Disease: Other/ General symptoms and signs; Signs and Symptoms; Specialty: Primary Care, Primary sub-specialty: Musculoskeletal disorders; Chronic pain

• Registration Number: ISRCTN49470934
• Lead Sponsor: niversity of Warwick

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31399456/ protocol (added 03/09/2020) 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31601587/ process evaluation protocol (added 22/10/2020) 2020 Protocol article in http://dx.doi.org/10.1136/bmjopen-2020-037243 health economics analysis protocol (added 27/11/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35296478/ intervention development and testing (added 18/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37219554/ (added 06/06/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/38056940/ Process evaluation (added 07/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-06
• Study Completion: 2021-11-11
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 608

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.