Clinical trial NCT01346423: Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Sick leave
musculoskeletal pain
return to work
multidisciplinary intervention
randomised controlled trial
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2011-05-03
Enrollment: 284
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: Inclusion Criteria:

* Musculoskeletal diagnosis
* Minimum 50% sick leave from work for not more than one year
* Minimum 50 % employed

Exclusion Criteria:

* Not sicklisted
* Sicklisted less than 50%
* Sicklisted \> 1 year
* Less than 50% employed
* Pregnancy
* Does not speak Norwegian
* Psychiatric disease
* Osteoporosis
* Cancer disease
* Rheumatic disease
* Ongoing Insurance Compensation Case

Primary outcomes:
measure: Change in Sickness leave 1 year after inclusion
timeFrame: At 12 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Dep. of Physica. Medicin and Rehabilitation, Innlandet Hospital Trust
Study officials:
affiliation: Sykehuset Innlandet HF
name: Eli M. Hagen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.