Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: The Stanford Chronic Pain Self-Management Programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic Pain Self-Management<br> | Behavioral: The Stanford Chronic Pain Self-Management Programme<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) |  | 10 weeks follow-up | 
| Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) |  | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989) |  | 10 weeks follow-up | 
| Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989) |  | 6 months follow-up | 
| Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization) |  | 6-months follow-up | 
| Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization) |  | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Stanford chronic pain self-management programme, Patient education