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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00840697
First received: February 9, 2009
Last updated: June 24, 2011
Last verified: May 2011
  Purpose

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 Intervention
Low Back Pain
Neck Pain
Behavioral: Exercises and work related rehabilitation
Behavioral: Brief intervention
Behavioral: multidisciplinary exercise group

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: Facilitating and Inhibiting Factors and Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • return to work rate [ Time Frame: week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost benefit, predictors (work, individual and health factors) of poor return to work rate, [ Time Frame: year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840697

Contacts
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

Locations
Norway
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
Investigators
Study Director: Erik Bautz-Holter, Professor Ullevaal University Hospital
  More Information

No publications provided

Responsible Party: Professor, PhD, Erik bautz-Holter, Ullevaal University Hospital, 0407 Oslo, Norway
ClinicalTrials.gov Identifier: NCT00840697     History of Changes
Other Study ID Numbers: return to work and exercise
Study First Received: February 9, 2009
Last Updated: June 24, 2011
Health Authority: Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
low back pain
neck pain
return to work
exercises
cognitive intervention

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

ClinicalTrials.gov processed this record on July 29, 2014