ISRCTN ISRCTN24426731
DOI https://doi.org/10.1186/ISRCTN24426731
Secondary identifying numbers V10 10.1.11, 69838
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

Study website

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

Study designPragmatic randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a 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 measurePain-related disability
Secondary outcome measures1. Health economics: Incremental Cost Utility Ratio (ICUR)
2. Coping skills, anxiety, depression, social integration and self efficacy
Overall study start date01/06/2011
Completion date23/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants700 (703 participants by end of recruitment)
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

  • England
  • United Kingdom

Study participating centre

Queen Mary University of London
London
E1 2AT
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Joint Research and Development Office
Queen Mary Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom

ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) – Programme Grants for Applied Research (RP-PG-0707-10189)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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