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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mehlsen M, Hegaard L, Ørnbøl E, Jensen JS, Fink P, Frostholm L. The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. Pain. 2017 Aug;158(8):1437-1445. doi: 10.1097/j.pain.0000000000000931.

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01306747 History of Changes
Other Study ID Numbers:	TACKLE2011
First Posted:	March 2, 2011
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