ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01306747
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : June 13, 2016
Sponsor:
Collaborators:
TRYG Foundation
Danish Committee for Health Education
Information provided by (Responsible Party):
University of Aarhus

Brief 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

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: The Stanford Chronic Pain Self-Management Programme Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
Study Start Date : February 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) [ Time Frame: 10 weeks follow-up ]
  2. Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) [ Time Frame: 6 months follow-up ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01306747     History of Changes
Other Study ID Numbers: TACKLE2011
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by University of Aarhus:
Chronic pain
Stanford chronic pain self-management programme
Patient education

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