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

February 18, 2011
April 12, 2013
February 2011
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01306747 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Pain
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.
  • Experimental: Chronic Pain Self-Management
    Intervention: Behavioral: The Stanford Chronic Pain Self-Management Programme
  • No Intervention: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
January 2014
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01306747
TACKLE2011
Yes
University of Aarhus
University of Aarhus
  • TRYG Foundation
  • Danish Committee for Health Education
Study Director: Per Fink, DMSc Aarhus University Hospital
University of Aarhus
April 2013

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