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Completed

NCT Number: NCT01306747

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Clinic for Functional Disorders, Aarhus University Hospital

Aarhus, Dk8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Stanford Chronic Pain Self-Management Programme

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.

Primary outcomes

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

    Time frame: 10 weeks follow-up

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

    Time frame: 6 months follow-up

Secondary outcomes

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

    Time frame: 10 weeks follow-up

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

    Time frame: 6 months follow-up

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

    Time frame: 6-months follow-up

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

    Time frame: 6 months follow-up

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Committee for Health Education
  • TRYG Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Mar 2, 2011
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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