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

NCT ID: NCT01306747

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Pain Self-Management

Group Type EXPERIMENTAL

The Stanford Chronic Pain Self-Management Programme

Intervention Type BEHAVIORAL

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

Danish Committee for Health Education

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Fink, DMSc

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

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The Research Clinic for Functional Disorders, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28644822 (View on PubMed)

Related Links

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Other Identifiers

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TACKLE2011

Identifier Type: -

Identifier Source: org_study_id

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