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

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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.

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014