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: January 19, 2015

Last verified: April 2013

History of Changes

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.

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

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:

MedlinePlus related topics: Chronic Pain

U.S. FDA Resources

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:	December 2015
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:	January 19, 2015
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 March 03, 2015

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