Transmural occupational care for low back pain, a randomised controlled trial and cost-effectiveness evaluation

ISRCTN	ISRCTN28478651
DOI	https://doi.org/10.1186/ISRCTN28478651
Secondary identifying numbers	NTR354

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof W. Mechelen, van
Scientific

VU Medical Center
Department of Social Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 4448410
Email	w.vanmechelen@vumc.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. Sick leave duration until full return-to-work 2. Functional status 3. Pain 4. Direct and indirect costs
Secondary outcome measures	1. Pain coping 2. Quality of life 3. Patient satisfaction
Overall study start date	15/03/2005
Completion date	15/03/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

VU Medical Center

Amsterdam
1007 MB
Netherlands

TNO Quality of Life (Work & Employment) (Netherlands)
Research organisation

P.O. Box 718
Hoofddorp
2130 AS
Netherlands

"ROR"	https://ror.org/01bnjb948

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Gak Institute Foundation (Stichting Instituut Gak [SIG])

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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