Condition category
Musculoskeletal Diseases
Date applied
06/04/2011
Date assigned
05/05/2011
Last edited
15/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icms.qmul.ac.uk/chs/pctu/current_projects/copers

Contact information

Type

Scientific

Primary contact

Dr Dawn Carnes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V10 10.1.11, 69838

Study information

Scientific title

COping with persistent Pain, Effectiveness Research in Self-management

Acronym

COPERS

Study hypothesis

Null 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

Cambridgeshire Research Ethics Committee 4, 18/03/2011, ref: 11/EE/0046

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Chronic musculoskeletal pain

Intervention

1. 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain-related disability

Secondary outcome measures

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

Overall trial start date

01/06/2011

Overall trial end date

23/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Adults (aged 18 or over) with chronic musculoskeletal pain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700 (703 participants by end of recruitment)

Participant exclusion criteria

1. 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

Recruitment start date

01/06/2011

Recruitment end date

23/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary University of London
London
E1 2AT
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23358564
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24231458
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24240140
2014 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/24528484
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27299859

Publication citations

  1. Protocol

    Carnes D, Taylor SJ, Homer K, Eldridge S, Bremner S, Pincus T, Rahman A, Underwood M, Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)., BMJ Open, 2013, 3, 1, doi: 10.1136/bmjopen-2012-002492.

  2. Results

    Carnes D, Homer K, Underwood M, Pincus T, Rahman A, Taylor SJ, Pain management for chronic musculoskeletal conditions: the development of an evidence-based and theory-informed pain self-management course., BMJ Open, 2013, 3, 11, e003534, doi: 10.1136/bmjopen-2013-003534.

  3. Results

    Mars T, Ellard D, Carnes D, Homer K, Underwood M, Taylor SJ, Fidelity in complex behaviour change interventions: a standardised approach to evaluate intervention integrity., BMJ Open, 2013, 3, 11, e003555, doi: 10.1136/bmjopen-2013-003555.

  4. Statistical analysis plan

    Kahan BC, Diaz-Ordaz K, Homer K, Carnes D, Underwood M, Taylor SJ, Bremner SA, Eldridge S, Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial., Trials, 2014, 15, 59, doi: 10.1186/1745-6215-15-59.

  5. Results

    Taylor SJ, Carnes D, Homer K, Kahan BC, Hounsome N, Eldridge S, Spencer A, Pincus T, Rahman A, Underwood M, Novel Three-Day, Community-Based, Nonpharmacological Group Intervention for Chronic Musculoskeletal Pain (COPERS): A Randomised Clinical Trial, PLoS Med, 2016, 13, 6, e1002040, doi: 10.1371/journal.pmed.1002040.

Additional files

Editorial Notes

15/06/2016: Publication reference added.