Musculoskeletal PainPhase 1/2NCT01356784
Returning to Work. Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" in Sicklisted Citizens With Chronic Musculoskeletal Pain
A Phase 1/2 study testing Tailored Physical Activity, "Chronic Pain Self-management Programme" and Health counselling in people with Musculoskeletal Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
TEst the effect of "Tailored Physical Activity" or "Chronic Pain Self-management Program" on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Tailored Physical Activity, "Chronic Pain Self-management Programme" and Health counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Apr 2014
- Phase
- Phase 1/2
- 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 to 66 years
- All sexes
- Adult, Older adult
Who may be able to join
- Sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in DK-Sønderborg Municipality
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" on Returning to Work: a Randomized Controlled Trial in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body
TEst the effect of "Tailored Physical Activity" or "Chronic Pain Self-management Program" on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body
Read the detailed description
Pain affects quality of life and it's important for the individual who experience chronic pain to find strategies to prevent or reduce pain. In some situations pain can't be reduced and the individual has to master pain by learning to live with it. Pain can lead to a loss of functions which may change one's roles both in relation to the family as to colleagues, for example sick leave from work.
Limited evidence is available on the effects of interventions to sick-listed citizens with chronic musculoskeletal pain.
This study test the effect of either "tailored physical activity or "Chronic Pain Self-management Program" on returning to work and the parameters pain, function and quality of life respectively on the body function and participation level of sick-listed people with chronic musculoskeletal pain related to columna and the upper body.
Citizens in DK-Sønderborg Municipality sick-listed for a maximum of 9 weeks will be invited. Participants will be randomized for either tailored physical activity, "Chronic Pain Self-Management Program" or reference group.
Primary endpoint is 3 months and 12 months follow-up.
- Conditions
- Musculoskeletal Pain
- Being tested
- Tailored Physical Activity, "Chronic Pain Self-management Programme", Health counselling
- Keywords
- Sick-listed, Tailored physical activity, Patient education, Returning to work, DK-Sønderborg Municipality, columna, upper body
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Physical ActivityOther
Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)
"Chronic Pain Self-management Programme"Behavioural
Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)
Health counsellingBehavioural
Health guidance (1,5h)
| Study group | Role | What they receive |
|---|---|---|
| Tailored Physical Activity | Experimental | Not described Receives: Other: Tailored Physical Activity |
| "Chronic Pain Self-management Programme" | Active comparator | Not described Receives: Behavioral: "Chronic Pain Self-management Programme" |
| Health Counselling | Other | Not described Receives: Behavioral: Health counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick-listed or not
Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.
Measured: 3 months
Secondary outcomes (9)
Aerobic capacity
Measured: 3 months
hand-grip strength
Measured: 3 months
Body weight, waist circumference, hip circumference
Measured: 3 months
Questionnaire
Measured: 3 months
Sick-listed or not
Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.
Measured: 12-months follow-up
Aerobic capacity
Measured: 12-months follow-up
Hand-grip strength
Measured: 12-months follow-up
Questionnaire
Measured: 12-months follow-up
Body weight, waist circumference, hip circumference
Measured: 12 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 posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2013
- Study completionApr 2014
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 Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- DK-Sønderborg Municipality
- Responsible party
- Principal investigator, Lotte Nygaard Andersen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356784
- Sponsor's protocol ID
- 95-154-32028
- Status last verified
- Apr 2014
- First submitted
- 13 May 2011
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial. BMC Public Health. 2013 Jan 23;13:66. doi: 10.1186/1471-2458-13-66.
PubMed 23343386
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" on Returning to Work: a Randomized Controlled Trial in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body
- ClinicalTrials.gov ID
- NCT01356784
- Acronym / sponsor ID
- 95-154-32028
- Conditions
- Musculoskeletal Pain
- Keywords
- Sick-listed, Tailored physical activity, Patient education, Returning to work, DK-Sønderborg Municipality, columna, upper body
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- DK-Sønderborg Municipality
- Study start
- May 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 May 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.
TEst the effect of "Tailored Physical Activity" or "Chronic Pain Self-management Program" on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body
Detailed description
Pain affects quality of life and it's important for the individual who experience chronic pain to find strategies to prevent or reduce pain. In some situations pain can't be reduced and the individual has to master pain by learning to live with it. Pain can lead to a loss of functions which may change one's roles both in relation to the family as to colleagues, for example sick leave from work.
Limited evidence is available on the effects of interventions to sick-listed citizens with chronic musculoskeletal pain.
This study test the effect of either "tailored physical activity or "Chronic Pain Self-management Program" on returning to work and the parameters pain, function and quality of life respectively on the body function and participation level of sick-listed people with chronic musculoskeletal pain related to columna and the upper body.
Citizens in DK-Sønderborg Municipality sick-listed for a maximum of 9 weeks will be invited. Participants will be randomized for either tailored physical activity, "Chronic Pain Self-Management Program" or reference group.
Primary endpoint is 3 months and 12 months follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored Physical Activity | Experimental | Other: Tailored Physical Activity |
| "Chronic Pain Self-management Programme" | Active comparator | Behavioral: "Chronic Pain Self-management Programme" |
| Health Counselling | Other | Behavioral: Health counselling |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in DK-Sønderborg Municipality
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tailored Physical ActivityHealth counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks) | Other | Tailored Physical Activity |
| "Chronic Pain Self-management Programme"Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks) | Behavioural | "Chronic Pain Self-management Programme" |
| Health counsellingHealth guidance (1,5h) | Behavioural | Health Counselling |
Primary outcome
Sick-listed or not
Time frame: 3 months
Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.
9 secondary outcomes
Aerobic capacity
Time frame: 3 months
hand-grip strength
Time frame: 3 months
Body weight, waist circumference, hip circumference
Time frame: 3 months
Questionnaire
Time frame: 3 months
Sick-listed or not
Time frame: 12-months follow-up
Aerobic capacity
Time frame: 12-months follow-up
Hand-grip strength
Time frame: 12-months follow-up
Questionnaire
Time frame: 12-months follow-up
Body weight, waist circumference, hip circumference
Time frame: 12 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 24 Apr 2014.
- Derived from this study: PubMed 23343386Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial. BMC Public Health. 2013 Jan 23;13:66. doi: 10.1186/1471-2458-13-66.
- University of Southern DenmarkLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tailored Physical Activity, "Chronic Pain Self-management Programme" and Health counselling in people with Musculoskeletal Pain, run by University of Southern Denmark 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 1 inclusion and 0 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 24 Apr 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sick-listed or not (time frame: 3 months). 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 NCT01356784, 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 24 Apr 2014.