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Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain

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ClinicalTrials.gov Identifier: NCT00840697
Recruitment Status : Unknown
Verified May 2011 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : February 10, 2009
Last Update Posted : June 27, 2011
The Research Council of Norway
Information provided by:
Oslo University Hospital

Brief Summary:

Low back pain is a usual condition in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines both Brief intervention and exercise/cognitive intervention are effective treatments with regard to pain and function (www.backpaineurope.org), but none have documented effect on return to work.

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 had also been evaluated in Amsterdam, by Dr. Anema with the same results.

At the Back Clinic, Ullevål University Hospital we are presently involved in a randomized controlled trial after the PREVICAP model, where patients are randomized to Brief intervention including a work-related intervention or usual care. All included patients in both groups, will have a clinical examination by specialist in Physical Medicine and Rehabilitation and advice from a physiotherapist. The current study replaces Brief intervention with an exercise - and a work-related program, so patients with non-specific LBP will be randomized to an exercise and work-related program or usual care.

The main purpose of this study

  • to investigate if rehabilitation programs specifically focusing on the return to work process will reduce sickness absence and disability pension in patients with neck and low back pain.
  • to assess the work-, individual- and health factors and their interrelationship predicting sickness absence and work disability.
  • to compare results from the rehabilitation program with results from rehabilitation program in Toronto
  • to which extent are the patients met by actions from employers and employment services, and does is influence sickness absence and disability.
  • do these actions represent favourable cost benefit for the work places and the society

Condition or disease Intervention/treatment Phase
Low Back Pain Neck Pain Behavioral: Exercises and work related rehabilitation Behavioral: Brief intervention Behavioral: multidisciplinary exercise group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitating and Inhibiting Factors and Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain
Study Start Date : August 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Work related rehabilitation

work related rehabilitation and exercises

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.

Exercises comprises of treatment in groups. The treatment includes exercises, both strength and fitness, in addition to cognitive intervention of how to manage pain and work.

Behavioral: Exercises and work related rehabilitation
Treatment in groups, twice a week for 3 weeks. The treatment includes exercises, cognitive intervention and work related rehabilitation. The exercises include fitness, strength and stretching
Other Names:
  • return to work
  • Low back pain
  • Behavioral

Active Comparator: Brief intervention
1 consultation at the physiotherapist, which give advise and a summary talk with the physician
Behavioral: Brief intervention
1 consultation at the physiotherapist, which give advice Summary talk with the physician about activity and work when having neck- and low back pain

Active Comparator: Multidisciplinary exercise group
10 days of exercise and cognitive treatment group
Behavioral: multidisciplinary exercise group
10 days during 3 weeks. Treatment in groups, exercise and cognitive treatment

Primary Outcome Measures :
  1. return to work rate [ Time Frame: week ]

Secondary Outcome Measures :
  1. Cost benefit, predictors (work, individual and health factors) of poor return to work rate, [ Time Frame: year ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with low back pain, sick listed for less than 1 year 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 with poor proficiency in Norwegian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840697

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Contact: Anne Keller, Dr.med.Sc +4723026451 anne.keller@medisin.uio.no
Contact: Erik Bautz-Holter, Professor +47 23026451 erik.bautz-holter@medisin.uio.no

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Ullevaal University Hospital Recruiting
Oslo, Norway, 0407
Contact: Anne Keller, Dr.med.Sc    +47 23026451    anne.keller@medisin.uio.no   
Contact: Roe Cecilie, Professor    +47 23026451    ecro@uus.no   
Principal Investigator: Kjersti Myhre, PhD student         
Sponsors and Collaborators
Ullevaal University Hospital
The Research Council of Norway
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Study Director: Erik Bautz-Holter, Professor Ullevaal University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor, PhD, Erik bautz-Holter, Ullevaal University Hospital, 0407 Oslo, Norway
ClinicalTrials.gov Identifier: NCT00840697    
Other Study ID Numbers: return to work and exercise
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: May 2011
Keywords provided by Oslo University Hospital:
low back pain
neck pain
return to work
cognitive intervention
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neck Pain
Neurologic Manifestations