The Sherbrooke Model

ISRCTN	ISRCTN60233560
DOI	https://doi.org/10.1186/ISRCTN60233560
Secondary identifying numbers	3140.0001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Willem Van Mechelen
Scientific

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8410
Email	w.van_mechelen.emgo@med.vu.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study acronym	ASE
Study objectives	A randomised controlled trial and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain.
Ethics approval(s)	The study design, protocols, procedures and informed consent form were approved by the Medical Ethics Committee of VU University Medical Centre, and all participants provided written, informed consent.
Health condition(s) or problem(s) studied	Non specific low back pain
Intervention	1. Participatory ergonomics 2. Graded activity 3. Usual care
Intervention type	Other
Primary outcome measure	Return to work. Outcome measures are assessed before randomisation (after 2 - 6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave.
Secondary outcome measures	Secondary outcome measures: 1. Pain intensity 2. Functional status 3. General improvement Intermediate variables: 1. Kinesiophobia 2. Pain coping Cost-effectiveness analysis: 1. Direct and indirect costs due to low back pain Outcome measures are assessed before randomisation (after 2 - 6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave.
Overall study start date	01/01/1999
Completion date	01/10/2002

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key inclusion criteria	Workers on sick leave for 2 to 6 weeks due to non specific low back pain.
Key exclusion criteria	1. Specific causes of low back pain: 1.1. Herniated discs with pareses 1.2. Paralysis 1.3. Spinal tumour 1.4. Spinal fracture 1.5. Ankylosing spondilitis 1.6. Spinal stenosis 1.7. Spondylolisthesis 1.8. Specific rheumatological diseases 1.9. Pregnancy 2. Serious psychiatric disorders 3. Legal conflict at work 4. Sick-listed due to low back pain less than one month prior to the current episode of sick leave
Date of first enrolment	01/01/1999
Date of final enrolment	01/10/2002

van der Boechorststraat 7

Amsterdam
1081 BT
Netherlands

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

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 3140.0001)

No information available

Dutch Ministries of Health, Welfare and Sports and of Social Affairs (The Netherlands)

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?
Protocol article	protocol	21/11/2003	Yes	No
Results article	results	01/02/2007	Yes	No
Results article	results	20/05/2009	Yes	No