Chronic PainNCT01306747
Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
A study testing The Stanford Chronic Pain Self-Management Programme in people with Chronic Pain, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- The Stanford Chronic Pain Self-Management Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Research Clinic for Functional Disorders, Aarhus University Hospital
Aarhus, Dk8000
About this study
Official title: 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.
Read more
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
- Conditions
- Chronic Pain
- Being tested
- The Stanford Chronic Pain Self-Management Programme
- Keywords
- Chronic pain, Stanford chronic pain self-management programme, Patient education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Stanford Chronic Pain Self-Management ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain Self-Management | Experimental | Not described Receives: Behavioral: The Stanford Chronic Pain Self-Management Programme |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Measured: 10 weeks follow-up
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Measured: 6 months follow-up
Secondary outcomes (4)
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Measured: 10 weeks follow-up
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Measured: 6 months follow-up
Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)
Measured: 6-months follow-up
Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Danish Committee for Health Education
- Responsible party
- Sponsor
- Investigators
- Per Fink, DMSc, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306747
- Sponsor's protocol ID
- TACKLE2011
- Status last verified
- Jun 2016
- First submitted
- 18 Feb 2011
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28644822
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT01306747
- Acronym / sponsor ID
- TACKLE2011
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Stanford chronic pain self-management programme, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TRYG Foundation, Danish Committee for Health Education
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain Self-Management | Experimental | Behavioral: The Stanford Chronic Pain Self-Management Programme |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Stanford Chronic Pain Self-Management ProgrammeThe 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. | Behavioural | Chronic Pain Self-Management |
Primary outcome
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Time frame: 10 weeks follow-up
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
Time frame: 6 months follow-up
4 secondary outcomes
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Time frame: 10 weeks follow-up
Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)
Time frame: 6 months follow-up
Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)
Time frame: 6-months follow-up
Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)
Time frame: 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Derived from this study: PubMed 28644822Mehlsen 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.
- Description of the program - In DanishLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Fink, DMSc study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Stanford Chronic Pain Self-Management Programme in people with Chronic Pain, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983) (time frame: 10 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01306747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.