Musculoskeletal DiseasesNCT01346423
Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain
A study testing Interdisciplinary intervention in people with Musculoskeletal Diseases, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Interdisciplinary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Jan 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Musculoskeletal diagnosis
- Minimum 50% sick leave from work for not more than one year
- Minimum 50 % employed
Who cannot join
- Not sicklisted
- Sicklisted less than 50%
- Sicklisted > 1 year
- Less than 50% employed
- Pregnancy
- Does not speak Norwegian
Show all 11Show fewer
- Psychiatric disease
- Osteoporosis
- Cancer disease
- Rheumatic disease
- Ongoing Insurance Compensation Case
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dep. of Physica. Medicin and Rehabilitation, Innlandet Hospital Trust
Ottestad, Ottestad, 2312
About this study
Official title: Is Interdisciplinary Intervention for Patients Sicklisted With Musculoskeletal Pain More Effective in Helping Patients Back to Work Than Than The Less Resource Demanding Brief Intervention Method?
Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported intensity of the complaints. Psychosocial factors are important in the development of chronic complaints. In a large meta-analysis job satisfaction was found to be associated with mental health and subjective physical health. Individual factors are also important. Uncertainty related to the understanding of pain mechanisms, treatment strategies and management contribute to the problem.
Among patients sicklisted for musculoskeletal complaints, low back pain is the largest diagnose group. Most of these patients also have many other complaints. Previous studies have shown that for low back pain patients a brief intervention at a spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, had significant effect in reducing sick leave. Other studies have shown that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain, and function.
Read more
A treatment team consisting of various professionals is expensive, and in this study we will compare the simple, standardized brief intervention model with the more resource demanding interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.
Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal complaints - is it beneficial for reducing sickness absence?
Read the detailed description
In 2007 The Government in Norway raised a fund to support efforts to reduce sickness absence, called "Raskere tilbake prosjekt". Helse Sør-Øst was invited to establish projects within their health care system, and the department of physical medicine and rehabilitation at Sykehuset Innlandet HF was assigned the task to constitute an outpatient-clinic for musculoskeletal diseases.
This initiative opened possibilities to explore new strategies based on science and own clinical experience to help these patients back to work without being confined to the traditional diagnose related examination and treatment offered in most clinics. In this project the main focus is directed towards work and barriers for working life. Because sickness absence often is multicausal and needs a bio-psycho-social approach, this should be reflected in the composition of the treatment team.
There is a great demand to make out how complex bio-psycho-social problems can be solved, organized, implemented, and have economic gains for the society. To answer these questions we need randomized controlled clinical studies, and we need documentation when new treatment models are offered to this group of patients.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Interdisciplinary intervention, Control Group, Brief Intervention
- Keywords
- Sick leave, musculoskeletal pain, return to work, multidisciplinary intervention, randomised controlled trial
- Medical subject headings
- Musculoskeletal Diseases, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary interventionBehavioural
Also called ISIVET, visual educational tool, interdisciplinary structured interview, multidisciplinary intervention
Interdisciplinary collaboration deals with tasks often complex which require different skills to make a wide assessment.In this study the treatment team consists of a physician, a physiotherapist and a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The conclusion of the team will be followed by a targeted rehabilitation plan. Factors assessed to be the major cause of the reduced function at work will have priority in the following rehabilitation process. One of the team members will be responsible for the further process to follow the plan to help the patient back to work, in cooperation with the patient, the workplace, the general practitioner, and NAV.
Control Group, Brief InterventionBehavioural
The brief intervention is a standardized intervention and the essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. The examination is thorough with detailed feedback on findings and normal functions, and clear and consistent explanations on pain and defense mechanisms. Somatic findings will be explained.Unless pathological findings, the patient will be encouraged to physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Treatment team with a physician, a physiotherapist, a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The patient meets at the outpatient clinic three times; at baseline, after 2 weeks and after 3 months. One year after baseline the patient has a telephone-follow-up. At baseline, the patient and the team works out a rehabilitation plan and in this process a new visual, educational tool is central. Receives: Behavioral: Interdisciplinary intervention |
| Controll group | Active comparator | The brief intervention is a standardized intervention based on the studies by Indahl and Hagen. Therapist treatment manuals will be written for the intervention. The essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. Unless symptoms and clinical findings indicate some serious disease, the patients will be informed about the good prognosis, and the importance of staying active to avoid development of muscle dysfunction. Receives: Behavioral: Control Group, Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sickness leave 1 year after inclusion
In addition to the main outcome we will also evaluate job satisfaction, social support, coping, defense mechanisms, illness perception, function level, activity of daily living, psychological distress, and health complaints/pain as recorded by the questionnaires at baseline.
Measured: At 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 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 DiseasesStudies of the same condition, open and under way.
- 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Eli M. Hagen, MD, PhD, Study chair, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346423
- Sponsor's protocol ID
- 150160
- Status last verified
- Mar 2011
- First submitted
- 14 Apr 2011
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Brendbekken R, Eriksen HR, Grasdal A, Harris A, Hagen EM, Tangen T. Return to Work in Patients with Chronic Musculoskeletal Pain: Multidisciplinary Intervention Versus Brief Intervention: A Randomized Clinical Trial. J Occup Rehabil. 2017 Mar;27(1):82-91. doi: 10.1007/s10926-016-9634-5.
PubMed 26910406
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Interdisciplinary Intervention for Patients Sicklisted With Musculoskeletal Pain More Effective in Helping Patients Back to Work Than Than The Less Resource Demanding Brief Intervention Method?
- ClinicalTrials.gov ID
- NCT01346423
- Acronym / sponsor ID
- 150160
- Conditions
- Musculoskeletal Diseases
- Keywords
- Sick leave, musculoskeletal pain, return to work, multidisciplinary intervention, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 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.
Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported intensity of the complaints. Psychosocial factors are important in the development of chronic complaints. In a large meta-analysis job satisfaction was found to be associated with mental health and subjective physical health. Individual factors are also important. Uncertainty related to the understanding of pain mechanisms, treatment strategies and management contribute to the problem.
Among patients sicklisted for musculoskeletal complaints, low back pain is the largest diagnose group. Most of these patients also have many other complaints. Previous studies have shown that for low back pain patients a brief intervention at a spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, had significant effect in reducing sick leave. Other studies have shown that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain, and function.
A treatment team consisting of various professionals is expensive, and in this study we will compare the simple, standardized brief intervention model with the more resource demanding interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.
Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal complaints - is it beneficial for reducing sickness absence?
Detailed description
In 2007 The Government in Norway raised a fund to support efforts to reduce sickness absence, called "Raskere tilbake prosjekt". Helse Sør-Øst was invited to establish projects within their health care system, and the department of physical medicine and rehabilitation at Sykehuset Innlandet HF was assigned the task to constitute an outpatient-clinic for musculoskeletal diseases.
This initiative opened possibilities to explore new strategies based on science and own clinical experience to help these patients back to work without being confined to the traditional diagnose related examination and treatment offered in most clinics. In this project the main focus is directed towards work and barriers for working life. Because sickness absence often is multicausal and needs a bio-psycho-social approach, this should be reflected in the composition of the treatment team.
There is a great demand to make out how complex bio-psycho-social problems can be solved, organized, implemented, and have economic gains for the society. To answer these questions we need randomized controlled clinical studies, and we need documentation when new treatment models are offered to this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Interdisciplinary interventionTreatment team with a physician, a physiotherapist, a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The patient meets at the outpatient clinic three times; at baseline, after 2 weeks and after 3 months. One year after baseline the patient has a telephone-follow-up. At baseline, the patient and the team works out a rehabilitation plan and in this process a new visual, educational tool is central. |
| Controll group | Active comparator | Behavioral: Control Group, Brief InterventionThe brief intervention is a standardized intervention based on the studies by Indahl and Hagen. Therapist treatment manuals will be written for the intervention. The essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. Unless symptoms and clinical findings indicate some serious disease, the patients will be informed about the good prognosis, and the importance of staying active to avoid development of muscle dysfunction. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Musculoskeletal diagnosis
- Minimum 50% sick leave from work for not more than one year
- Minimum 50 % employed
Key exclusion criteria (11 listed)
- Not sicklisted
- Sicklisted less than 50%
- Sicklisted > 1 year
- Less than 50% employed
- Pregnancy
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 |
|---|---|---|
| Interdisciplinary interventionAlso: ISIVET, visual educational tool, interdisciplinary structured interview, multidisciplinary interventionInterdisciplinary collaboration deals with tasks often complex which require different skills to make a wide assessment.In this study the treatment team consists of a physician, a physiotherapist and a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The conclusion of the team will be followed by a targeted rehabilitation plan. Factors assessed to be the major cause of the reduced function at work will have priority in the following rehabilitation process. One of the team members will be responsible for the further process to follow the plan to help the patient back to work, in cooperation with the patient, the workplace, the general practitioner, and NAV. | Behavioural | Intervention group |
| Control Group, Brief InterventionThe brief intervention is a standardized intervention and the essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. The examination is thorough with detailed feedback on findings and normal functions, and clear and consistent explanations on pain and defense mechanisms. Somatic findings will be explained.Unless pathological findings, the patient will be encouraged to physical activity. | Behavioural | Controll group |
Primary outcome
Change in Sickness leave 1 year after inclusion
Time frame: At 12 months after baseline
In addition to the main outcome we will also evaluate job satisfaction, social support, coping, defense mechanisms, illness perception, function level, activity of daily living, psychological distress, and health complaints/pain as recorded by the questionnaires at baseline.
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 3 Aug 2016.
- Derived from this study: PubMed 26910406Brendbekken R, Eriksen HR, Grasdal A, Harris A, Hagen EM, Tangen T. Return to Work in Patients with Chronic Musculoskeletal Pain: Multidisciplinary Intervention Versus Brief Intervention: A Randomized Clinical Trial. J Occup Rehabil. 2017 Mar;27(1):82-91. doi: 10.1007/s10926-016-9634-5.
- Info about the project: Raskere tilbakeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Eli M. Hagen, MD, PhD study chair
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary intervention in people with Musculoskeletal Diseases, run by Sykehuset Innlandet HF at 1 site in Norway.
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 3 inclusion and 11 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 3 Aug 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 Norway. 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?
Change in Sickness leave 1 year after inclusion (time frame: At 12 months after baseline). 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 NCT01346423, 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 3 Aug 2016.