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Transmural occupational care for low back pain, a randomised controlled trial and cost-effectiveness evaluation
ISRCTN ISRCTN28478651
DOI 10.1186/ISRCTN28478651
ClinicalTrials.gov identifier
EudraCT number
Public title Transmural occupational care for low back pain, a randomised controlled trial and cost-effectiveness evaluation
Scientific title
Acronym Bridge study
Serial number at source NTR354
Study hypothesis 1. Is occupational transmural care for workers visiting outpatient clinics of a hospital more (cost-)effective on return-to-work than usual clinical medical care?
2. How is the program for transmural occupational care and its implementation (i.e. the applicability, compliance to, satisfaction, barriers) evaluated by patients with LBP, their employer and their health care professionals?
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Low back pain (LBP)
Participants - inclusion criteria 1. Non-specific and specific low back pain, lasting more than 6 weeks
2. Sick listed due to low back pain (completely or partially)
3. Between 18 and 65 years of age
4. Employed in a company or organisation
5. Ability to complete questionnaires written in the Dutch language
Participants - exclusion criteria 1. Specific low back pain due to spinal tumor; spinal fracture; or spinal inflammation
2. Cardiological diseases which hamper physical activity
3. Juridical conflict at work
4. Psychosis
5. Pregnancy; until 3 months after giving birth
6. Back surgery; until 6 weeks after
Anticipated start date 15/03/2005
Anticipated end date 15/03/2009
Status of trial Completed
Patient information material
Target number of participants 160
Interventions 1. Graded Activity protocol. Based on a cognitive behavioral program. It will be applied by a physical therapist.
2. Work(place) adaptations. Based on active participation and strong commitment of both the worker and the employer. It will be applied by a occupational therapist.
Primary outcome measure(s) 1. Sick leave duration until full return-to-work
2. Functional status
3. Pain
4. Direct and indirect costs
Secondary outcome measure(s) 1. Pain coping
2. Quality of life
3. Patient satisfaction
Sources of funding 1. Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
2. Gak Institute Foundation (Stichting Instituut Gak [SIG])
Trial website
Publications 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17883853
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19943976
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20234040
Contact name Prof  W.  Mechelen, van
  Address VU Medical Center
Department of Social Medicine
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
  Tel +31 (0)20 4448410
  Email w.vanmechelen@vumc.nl
Sponsor TNO Quality of Life (Work & Employment) (Netherlands)
  Address P.O. Box 718
  City/town Hoofddorp
  Zip/Postcode 2130 AS
  Country Netherlands
Date applied 19/12/2005
Last edited 18/03/2010
Date ISRCTN assigned 19/12/2005
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