Work Related Rehabilitation in Patients With Low Back Pain

NCT00526604 | Terminated Phase 3 DMC

• 1 other identifier: Work and LBP
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

return to work; low back pain; work related rehabilitation

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is return to work, measured in number of days patients have been sick listed in both groups.

  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.

Secondary Outcomes (1)

• The secondary outcome measures are improvement in pain, function, stiffness and fear-avoidance beliefs

  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.

Study Arms (1)

2

ACTIVE COMPARATOR

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

Interventions

work related rehabilitation BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Anne Keller

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Keller, Dr.Med.Sc

  Dep of Physical Medicine and Rehab, Ulleval University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: January 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2008-12

Locations

NO (1)