|- candidate number||1551|
|- NTR Number||NTR354|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Transmural occupational care for low back pain, A randomised controlled trial and cost-effectiviness evalution.|
|- Scientific Title||Transmural occupational care for low back pain, A randomised controlled trial and cost-effectiviness evalution.|
|- ACRONYM||Bridge 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?|
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP)|
|- Inclusion criteria||1. Non-specific and specific low back pain, lasting more than 6 weeks;|
2. Sicklisted due to low back pain (completely of 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.
|- Exclusion criteria||1. Specific low back pain due to spinal tumor; spinal fracture; or spinal inflammation;|
2. Cardiological diseases which hamper fysical activity;
3. Juridical confict at work;
5. Pregnancy; till 3 month after giving birth;
6. Back surgery; till 6 weeks after.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||15-mrt-2005|
|- planned closingdate||15-mrt-2009|
|- Target number of participants||130|
|- Interventions||Graded Activity protocol. Based on a cognitive behavioral program. It will be applied by a physical therapist.
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||1. Sickleave duration until full return-to-work;
2. Functional status;
4. Direct and indirects costs.|
|- Secondary outcome||1. Pain coping
2. Quality of life;
3. Patiens satisfaction.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. W. Mechelen, van |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W. Mechelen, van |
|- Sponsor/Initiator ||TNO Quality of Life (Work and Employment), VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Instituut GAK (SIG)|
|- Brief summary||Most of the costs related to low back pain (LBP) are due to sickleave and disability of a relatively small group of workers with long-term sickleave absence. However, usual medical care of these patients is not aimed at return-to-work. |
Occupational interventions have proven to be (cost-)effective for return-to-work of low back pain patients in primary care, but the (cost-)effectiveness of these interventions has not yet been established for patients in a secondary care setting.
To reduce sickleave and occupational disability of patients with LBP in secondary care, in this study transmural care, including occupational interventions, will be evaluated.
The transmural occupational care will be provided to patients with sickleave due to nonspecific and specific LBP, visiting outpatient clinics of the Vumc, the Slotervaart hospital and the Amstelland hospital (e.g. Orthopaedics, Neurosurgery, Neurology and Rheumatology).
After a medical and sociopsychological screening for LBP, the transmural care is applied by a multidisciplinary team consisting of a transmural occupational physician (OP), a clinical medical specialist, an occupational therapist and a physical therapist.
The occupational care will comprise of work(place) adaptations and a graded activity training program.
Patients will be randomised to transmural occupational care or usual clinical care (n=2 x 72).
Outcome measures are: sickleave duration, functional status, pain, and direct and indirect costs. Measurements will take place at baseline, 12, 26 and 52 weeks after inclusion.
The main research question in this study is: Is transmural occupational care of patients with LBP, visiting outpatient clinic of the VUmc, more (cost-) effective on return-to-work than usual clinical medical care?
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 18-mei-2007|