Condition category
Musculoskeletal Diseases
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W. Mechelen, van

ORCID ID

Contact details

VU Medical Center
Department of Social Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4448410
w.vanmechelen@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR354

Study information

Scientific title

Acronym

Bridge study

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?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/03/2005

Overall trial end date

15/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

15/03/2005

Recruitment end date

15/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

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

Sponsor details

P.O. Box 718
Hoofddorp
2130 AS
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Gak Institute Foundation (Stichting Instituut Gak [SIG])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Lambeek LC, Anema JR, van Royen BJ, Buijs PC, Wuisman PI, van Tulder MW, van Mechelen W, Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651]., BMC Public Health, 2007, 7, 254, doi: 10.1186/1471-2458-7-254.

  2. Results

    Lambeek LC, van Mechelen W, Buijs PC, Loisel P, Anema JR, An integrated care program to prevent work disability due to chronic low back pain: a process evaluation within a randomized controlled trial., BMC Musculoskelet Disord, 2009, 10, 147, doi: 10.1186/1471-2474-10-147.

  3. Results

    Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR, Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life., BMJ, 2010, 340, c1035.

Additional files

Editorial Notes