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

June 10, 2016 updated by: University of Aarhus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, Dk8000
        • The Research Clinic for Functional Disorders, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

TRYG Foundation
Danish Committee for Health Education

Investigators

  • Study Director: Per Fink, DMSc, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACKLE2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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