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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2011

Last Updated Date

April 12, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01306747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Pain

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Chronic Pain Self-Management
Intervention: Behavioral: The Stanford Chronic Pain Self-Management Programme
No Intervention: Control group

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2014

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01306747

Other Study ID Numbers ^ICMJE

TACKLE2011

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

TRYG Foundation
Danish Committee for Health Education

Investigators ^ICMJE

Study Director:

Per Fink, DMSc

Aarhus University Hospital

Information Provided By

University of Aarhus

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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