Work Related Rehabilitation in Patients With Low Back Pain

This study has been terminated.
(The study was stopped, as the another multicentre-RCT on the same patients started.)
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00526604
First received: September 6, 2007
Last updated: July 3, 2011
Last verified: December 2008
  Purpose

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 Intervention Phase
Low Back Pain
Behavioral: work related rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study on the Effect of Employment Follow-up on Return to Work in Sick Listed Patients With Low Back Pain

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: January 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non-specific low back pain sick listed from 6-8 weeks and who are permanently employed.

Exclusion Criteria:

  • Patients with infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis/ listesis, serious somatic disease and/or psychic disease and patients with a poor proficiency in Norwegian.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00526604

Locations
Norway
Anne Keller
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Anne Keller, Dr.Med.Sc Dep of Physical Medicine and Rehab, Ulleval University Hospital, Oslo, Norway
  More Information

No publications provided

Responsible Party: Anne Keller, Ulleval University Hospital, 0407 Oslo, Norway
ClinicalTrials.gov Identifier: NCT00526604     History of Changes
Other Study ID Numbers: Work and LBP
Study First Received: September 6, 2007
Last Updated: July 3, 2011
Health Authority: Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
return to work
low back pain
work related rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014