Transmural occupational care for low back pain, a randomised controlled trial and cost-effectiveness evaluation
| ISRCTN | ISRCTN28478651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28478651 |
| Protocol serial number | NTR354 |
| Sponsor | TNO Quality of Life (Work & Employment) (Netherlands) |
| Funders | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Gak Institute Foundation (Stichting Instituut Gak [SIG]) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 18/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W. Mechelen, van
Scientific
Scientific
VU Medical Center
Department of Social Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4448410 |
|---|---|
| w.vanmechelen@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Bridge study |
| Study objectives | 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? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Low back pain (LBP) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Sick leave duration until full return-to-work |
| Key secondary outcome measure(s) |
1. Pain coping |
| Completion date | 15/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/03/2005 |
| Date of final enrolment | 15/03/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/09/2007 | Yes | No | |
| Results article | results | 30/11/2009 | Yes | No | |
| Results article | results | 16/03/2010 | Yes | No |
