Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
This study is ongoing, but not recruiting participants.
Sponsor:
University of Aarhus
Collaborators:
TRYG Foundation
Danish Committee for Health Education
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01306747
First received: February 18, 2011
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500 chronic pain patients is randomized into either an CPSMP intervention group or a control group.
The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors are not health professionals but chronic pain patient themselves. The program is highly structured and manualized.
Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and well-being. Hence we expect the CPSMP to have an effect on various domains.
- Symptom reduction - lower self-reported pain in the CPSMP group compared to controls
- Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy
- Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls
- Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls
| Condition | Intervention |
|---|---|
|
Chronic Pain |
Behavioral: The Stanford Chronic Pain Self-Management Programme |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) [ Time Frame: 10 weeks follow-up ] [ Designated as safety issue: No ]
- Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989) [ Time Frame: 10 weeks follow-up ] [ Designated as safety issue: No ]
- Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989) [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
- Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization) [ Time Frame: 6-months follow-up ] [ Designated as safety issue: No ]
- Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization) [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chronic Pain Self-Management |
Behavioral: The Stanford Chronic Pain Self-Management Programme
The Stanford CPSMP is a patient education program consisting of six 2½ hour weekly sessions. Two trained instructors teach a group of 8-16 persons about managing pain.
|
| No Intervention: Control group |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pain in more than 3 months
- Self-reported pain > 4.99 on 10 point Likert scale
- Age > 18 years old
- Able to understand, speak, and read Danish
Exclusion Criteria:
- Pain related to conditions that the patient are likely to consider more important than pain itself, e.g. pregnancy, cancer in acute phases
- Drug abuse, psychiatric or physical disease that would prevent participation in weekly sessions
- Drug abuse, psychiatric or physical disease that would disturb completion of group sessions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306747
Locations
| Denmark | |
| The Research Clinic for Functional Disorders, Aarhus University Hospital | |
| Aarhus, Denmark, Dk8000 | |
Sponsors and Collaborators
University of Aarhus
TRYG Foundation
Danish Committee for Health Education
Investigators
| Study Director: | Per Fink, DMSc | Aarhus University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01306747 History of Changes |
| Other Study ID Numbers: | TACKLE2011 |
| Study First Received: | February 18, 2011 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Chronic pain Stanford chronic pain self-management programme Patient education |
ClinicalTrials.gov processed this record on May 16, 2013