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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306747
• Other study ID #: TACKLE2011
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: June 10, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls

2. Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy

3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls

4. Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Research Clinic for Functional Disorders, Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Danish Committee for Health Education, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)		10 weeks follow-up	No
Primary	Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)		6 months follow-up	No
Secondary	Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)		10 weeks follow-up	No
Secondary	Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)		6 months follow-up	No
Secondary	Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)		6-months follow-up	No
Secondary	Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)		6 months follow-up	No