Work Related Rehabilitation in Patients With Low Back Pain
|ClinicalTrials.gov Identifier: NCT00526604|
Recruitment Status : Terminated (The study was stopped, as the another multicentre-RCT on the same patients started.)
First Posted : September 10, 2007
Last Update Posted : July 6, 2011
Low back pain is a usual conditions in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines are exercise and cognitive intervention effective on pain and function(www.backpaineurope.org), but it have no documented effect on return to work. In addition, there is no documentation that treatments which focus on a single treatment, is effective with regard to return to work for sick-listed patients.
The challenges for health personnel is not cure of the patients back pain, but to build up rehabilitation programs which focus on disability and work incapacity, in patients which are at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated patients with back pain according to the "The PREVICAP model - (PREVention of work handICAP)", where the main purpose with work-related program is to prevent prolonged disability and to help patients back to work. Loisel demonstrated that the PREVICAP models accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model have also been evaluated in Amsterdam, by Dr. Anema with the same results.
At the Back Clinic, Ullevål University Hospital we have evaluated several exercise programs with good effect on pain and function, but not on the return to work rate. We are planning to do a randomized controlled trial after the PREVICAP model. All included patients in both groups, will have an clinical examination by specialist in Physical Medicine and Rehabilitation and an exercise program. Patients will be randomized to a work-related rehabilitations program or to usual care by the general practitioner.
Hypothesis Main hypothesis: Sick-listed patients with back pain, who will be randomized to the work-related rehabilitation programs, will return to work faster than patients randomized to usual care by the general practitioner.
Second hypothesis: A cost-benefit analysis will favor the exercise program and work place intervention
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Behavioral: work related rehabilitation||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Study on the Effect of Employment Follow-up on Return to Work in Sick Listed Patients With Low Back Pain|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
Active Comparator: 2
The control group will have an clinical examination and exercise and then return to general practitioner, which will take decision about sick leave or return to work.
Behavioral: work related rehabilitation
The workplace intervention includes two steps:
Evaluations of the work site: The occupational ergonomists task is to identify conditions at the work site, as for instance ergonomic, work demand and relations to the employer and colleagues.
Therapeutic Return to work: The occupational ergonomists will organize contacts and meetings between the employer and the patients and make a schedule for return to work. The therapeutic return-to-work-process will take place at the work place, with progressively more days at work and progressively increasing tasks.
- The primary outcome measure is return to work, measured in number of days patients have been sick listed in both groups. [ Time Frame: The duration of the project is estimated to 3 years. The project will start January1st 2008 and the inclusion of patients and the follow-up will be in 2008 and 2009. In 2010 follow-up, statistical analyses, writing and publishing the articles. ]
- The secondary outcome measures are improvement in pain, function, stiffness and fear-avoidance beliefs [ Time Frame: The duration of the project is estimated to 3 years. The project will start January 1st 2008 and the inclusion of patients and the follow-up will be in 2008 and 2009. In 2010 follow-up, statistical analyses, writing and publishing the articles. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526604
|Oslo, Norway, 0407|
|Principal Investigator:||Anne Keller, Dr.Med.Sc||Dep of Physical Medicine and Rehab, Ulleval University Hospital, Oslo, Norway|