ISRCTN ISRCTN24426731
DOI https://doi.org/10.1186/ISRCTN24426731
Protocol serial number V10 10.1.11, 69838
Sponsor Queen Mary University of London (UK)
Funder National Institute for Health Research (NIHR) (UK) – Programme Grants for Applied Research (RP-PG-0707-10189)
Submission date
06/04/2011
Registration date
05/05/2011
Last edited
11/06/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dawn Carnes
Scientific

Centre for Health Sciences
Queen Mary University of London
2 Newark Street
London
E1 2AT
United Kingdom

Study information

Primary study designInterventional
Study designPragmatic randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCOping with persistent Pain, Effectiveness Research in Self-management
Study acronymCOPERS
Study objectivesNull Hypothesis - There is no difference in pain related disability between those exposed to the self-management chronic pain course and those with usual GP care plus relaxation.
Ethics approval(s)Cambridgeshire Research Ethics Committee 4, 18/03/2011, ref: 11/EE/0046
Health condition(s) or problem(s) studiedChronic musculoskeletal pain
Intervention1. To test the effectiveness of a self-management course for chronic pain against a control consisting of usual GP care, a patient education leaflet and a relaxation CD.
2. The intervention is a group based, facilitated learning course about coping strategies for living with chronic pain
3. The course is led by a health care professional and a lay person with chronic pain. We aim to have around 12 participants per course
4. The course will cover various aspects of pain education, pain management techniques, posture and movement
5. It will be run over three days within one week with a two hour follow up session after two weeks
Intervention typeOther
Primary outcome measure(s)

Pain-related disability

Key secondary outcome measure(s)

1. Health economics: Incremental Cost Utility Ratio (ICUR)
2. Coping skills, anxiety, depression, social integration and self efficacy

Completion date23/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration703
Key inclusion criteriaAdults (aged 18 or over) with chronic musculoskeletal pain
Key exclusion criteria1. Not fluent in English
2. Serious active co-morbidity that is more disabling to the individual than chronic pain
3. Serious mental health issues that would make it difficult for an individual to participate in the group course
4. Patients with a life expectancy of less than six months
5. Substance misuse that would make it difficult for an individual to participate in the group course
6. Inability to give informed consent
Date of first enrolment01/06/2011
Date of final enrolment23/07/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Queen Mary University of London
London
E1 2AT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/11/2013 Yes No
Results article results 15/11/2013 Yes No
Results article results 14/06/2016 Yes No
Results article cohort analysis results 06/06/2018 Yes No
Protocol article protocol 28/01/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Statistical Analysis Plan statistical analysis plan 15/02/2014 No No
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

11/06/2018: Publication reference added.
15/06/2016: Publication reference added.