Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.
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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.
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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.
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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.
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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.