NCT01306747

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. 1.Symptom reduction - lower self-reported pain in the CPSMP group compared to controls
  2. 2.Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy
  3. 3.Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls
  4. 4.Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

February 18, 2011

Last Update Submit

June 10, 2016

Conditions

Chronic Pain

Keywords

Chronic painStanford chronic pain self-management programmePatient education

Outcome Measures

Primary Outcomes (2)

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

    10 weeks follow-up

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

    6 months follow-up

Secondary Outcomes (4)

  • Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)

    10 weeks follow-up

  • Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)

    6 months follow-up

  • Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)

    6-months follow-up

  • Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)

    6 months follow-up

Study Arms (2)

Chronic Pain Self-Management

EXPERIMENTAL
Behavioral: The Stanford Chronic Pain Self-Management Programme

Control group

NO INTERVENTION

Interventions

The Stanford Chronic Pain Self-Management ProgrammeBEHAVIORAL

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.

Chronic Pain Self-Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Research Clinic for Functional Disorders, Aarhus University Hospital

Aarhus, Dk8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28644822DERIVED

Related Links

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per Fink, DMSc

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2015

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

DK(1)