The Sherbrooke Model

ISRCTN	ISRCTN60233560
DOI	https://doi.org/10.1186/ISRCTN60233560
Protocol serial number	3140.0001
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 3140.0001), Dutch Ministries of Health, Welfare and Sports and of Social Affairs (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/10/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/02/2007	Yes	No
Results article	results	20/05/2009	Yes	No
Protocol article	protocol	21/11/2003	Yes	No