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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The Stanford Chronic Pain Self-Management Programme
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Stanford chronic pain self-management programme, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Research Clinic for Functional Disorders, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chronic Pain Self-Management

Control group

Arm Description

Outcomes

Primary Outcome Measures

Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)

Secondary Outcome Measures

Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)
Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)

Full Information

First Posted
February 18, 2011
Last Updated
June 10, 2016
Sponsor
University of Aarhus
Collaborators
TRYG Foundation, Danish Committee for Health Education
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1. Study Identification

Unique Protocol Identification Number
NCT01306747
Brief Title
Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
Official Title
A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
TRYG Foundation, Danish Committee for Health Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Stanford chronic pain self-management programme, Patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic Pain Self-Management
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
The Stanford Chronic Pain Self-Management Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Time Frame
10 weeks follow-up
Title
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Time Frame
10 weeks follow-up
Title
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Time Frame
6 months follow-up
Title
Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)
Time Frame
6-months follow-up
Title
Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)
Time Frame
6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Fink, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Research Clinic for Functional Disorders, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
Dk8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28644822
Citation
Mehlsen M, Hegaard L, Ornbol 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.
Results Reference
derived

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

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