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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00369135
Other study ID # NFP-111-111
Secondary ID
Status Recruiting
Phase N/A
First received August 25, 2006
Last updated November 20, 2008
Start date March 2006
Est. completion date February 2009

Study information

Verified date November 2008
Source Institut Universitaire Romand de Sante au Travail
Contact Danuser Brigitta, Prof.
Phone +41 021-314-7421
Email Brigitta.Danuser@hospvd.ch
Is FDA regulated No
Health authority Switzerland: Swiss National Science Foundation
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date February 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 58 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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"

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Procedure:
combined intervention


Locations

Country Name City State
Switzerland Institut universitaire romand de Santè au Travail Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Institut Universitaire Romand de Sante au Travail

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sick-day saving, work capacity, economic variables one year
Secondary Functional performance, pain, general health, variables related to coping, believes, anxiety, depression one year
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