Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain
| Tracking Information | |||||
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| First Received Date ICMJE | April 14, 2011 | ||||
| Last Updated Date | October 23, 2012 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Sickness leave 1 year after inclusion [ Time Frame: At 12 months after baseline ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01346423 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain | ||||
| Official Title ICMJE | 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? | ||||
| Brief 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 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? |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Musculoskeletal Diseases | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01346423 | ||||
| Other Study ID Numbers ICMJE | 150160 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sykehuset Innlandet HF | ||||
| Study Sponsor ICMJE | Sykehuset Innlandet HF | ||||
| Collaborators ICMJE | University of Bergen | ||||
| Investigators ICMJE |
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| Information Provided By | Sykehuset Innlandet HF | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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