Back PainNCT00369135
Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal Disorders
A study testing combined intervention in people with Back Pain and Neck Pain, run by Institut Universitaire Romand de Sante au Travail at 1 site in Switzerland.
Trial summary
Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all industrial countries including Switzerland. Despite much progress as to the cause and prevention of MSDs, they continue to be some of the most prevalent and challenging health problems with respect to the work-place and to… Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Back Pain, Neck Pain, Musculoskeletal Abnormalities
- What is being tested?
- combined intervention
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2006to Feb 2009
- 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 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Employees on sick leave because of non-specific back and/or neck/shoulder pain
- actual unable to work and continuous or cumulative (totalized) work incapa- city in the past 6 monts
- ≥ 20 working days 100% absence from work or
- ≥ 40 working days 80 to 99% absence from work or
- ≥ 60 working days 50 to 79% absence from work and
- not older than 58 level of employment ≥ 50%
- no longer than 6 monts absencer from work (100% unable to work)
Who cannot join
- Specific diagnosis such as infection, neoplasm, metastasis osteoporosis, rheumatoid arthritis, fracture and inflammatory process or other conditions for which valid diagnoses had been demonstrated either in the anamnesis, records or the clinical examination
- Postoperative health condition with prohibited physical load
- Major co-morbidity which may determine return to work in a clearly stronger way then the MSD itself such as a major depression, psychosis, heavy drug or alcohol disease or instable cardiac or pulmonary disease
- Predominant specific shoulder pathology in "neck-shoulder pain"
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Institut universitaire romand de Santè au Travail
Lausanne
About this study
Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all industrial countries including Switzerland. Despite much progress as to the cause and prevention of MSDs, they continue to be some of the most prevalent and challenging health problems with respect to the work-place and to socio-economic burden.
To improve the situation, several recent reviews recommended interventions based on the bio-psycho-social model. Work-hardening and industrial rehabilitation programs focused more on the in balance between physical and mental demands of work on one side and capacities of the individual on the other side. Therefore we propose to merge the two models into one. The result is an interdisciplinary intervention strategy witch includes work hardening, medical trainings, a cognitive behavioural approach and work place intervention.
- Conditions
- Back Pain, Neck Pain, Musculoskeletal Abnormalities
- Being tested
- combined intervention
- Keywords
- work, Musculoskeletal Disorders
- Medical subject headings
- Back Pain, Neck Pain, Musculoskeletal Abnormalities, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined interventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick-day saving, work capacity, economic variables
Measured: one year
Secondary outcomes (1)
Functional performance, pain, general health, variables related to coping, believes, anxiety, depression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Universitaire Romand de Sante au Travail
- Sponsor type
- University, hospital or other
- Investigators
- Danuser Brigitta, Prof, Study director, Institut Universitaire Romand de Sante au Travail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369135
- Sponsor's protocol ID
- NFP-111-111
- Status last verified
- Nov 2008
- First submitted
- 25 Aug 2006
- Last updated
- 21 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT00369135
- Acronym / sponsor ID
- NFP-111-111
- Conditions
- Back Pain, Neck Pain, Musculoskeletal Abnormalities
- Keywords
- work, Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut Universitaire Romand de Sante au TravailUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Feb 2009 (estimated)
- First posted
- 29 Aug 2006 (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.
Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all industrial countries including Switzerland. Despite much progress as to the cause and prevention of MSDs, they continue to be some of the most prevalent and challenging health problems with respect to the work-place and to socio-economic burden.
To improve the situation, several recent reviews recommended interventions based on the bio-psycho-social model. Work-hardening and industrial rehabilitation programs focused more on the in balance between physical and mental demands of work on one side and capacities of the individual on the other side. Therefore we propose to merge the two models into one. The result is an interdisciplinary intervention strategy witch includes work hardening, medical trainings, a cognitive behavioural approach and work place intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Employees on sick leave because of non-specific back and/or neck/shoulder pain
- actual unable to work and continuous or cumulative (totalized) work incapa- city in the past 6 monts
- ≥ 20 working days 100% absence from work or
- ≥ 40 working days 80 to 99% absence from work or
- ≥ 60 working days 50 to 79% absence from work and
Key exclusion criteria (4 listed)
- Specific diagnosis such as infection, neoplasm, metastasis osteoporosis, rheumatoid arthritis, fracture and inflammatory process or other conditions for which valid diagnoses had been demonstrated either in the anamnesis, records or the clinical examination
- Postoperative health condition with prohibited physical load
- Major co-morbidity which may determine return to work in a clearly stronger way then the MSD itself such as a major depression, psychosis, heavy drug or alcohol disease or instable cardiac or pulmonary disease
- Predominant specific shoulder pathology in "neck-shoulder pain"
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 |
|---|---|---|
| combined intervention | Procedure or surgery | – |
Primary outcome
Sick-day saving, work capacity, economic variables
Time frame: one year
1 secondary outcome
Functional performance, pain, general health, variables related to coping, believes, anxiety, depression
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2008.
- Click here for more information about this study: Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal DisordersLink 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.
Danuser Brigitta, Prof study director
Institut Universitaire Romand de Sante au Travail
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined intervention in people with Back Pain and Neck Pain, run by Institut Universitaire Romand de Sante au Travail at 1 site in Switzerland.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Nov 2008. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danuser Brigitta, Prof. (+41 021-314-7421 ext. 0041, Brigitta.Danuser@hospvd.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick-day saving, work capacity, economic variables (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2008.