Contact information
Type
Scientific
Primary contact
Prof. W. van Mechelen
ORCID ID
Contact details
Vrije University Medical Centre (VUMC)
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
N/A
Study information
Scientific title
Acronym
AGAS
Study hypothesis
A behaviour-oriented physical exercise program (graded activity) is more effective than usual care in sick-listed workers with low back pain with regard to return to work, disability, pain and pain-related fears.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, single blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Low back pain
Intervention
Graded activity:
The graded activity intervention consisted of two sessions of physical exercises a week until full return to regular work was achieved. The intervention was supervised by skilled physiotherapists. During the course of the intervention the load of the exercises was gradually increased towards a preset exercise goal, following a time-contingent exercise scheme. The exercise goals were connected with return-to-work goals. The intervention had a maximum duration of three months.
Usual care:
The workers who were allocated to the usual care group received the usual guidance by the occupational physician. There were no special requirements for other treatments except that the workers were not allowed to attend treatment sessions at the same physiotherapy practice where the workers of the graded activity group were treated.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Days of sick leave due to low back pain
2. Disability
3. Pain
Secondary outcome measures
Pain-related fears
Overall trial start date
01/04/1999
Overall trial end date
31/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Sick leave because of non-specific low back pain. This could be either full or partial sick leave
2. A minimum duration of the complaints of four weeks in succession
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
134
Participant exclusion criteria
1. Radiation below the knee in combination with signs of nerve root compression
2. Cardiovascular contra-indications for physical activity, as checked by the Physical Activities Readiness Questionnaire
3. A conflict between worker and employer with legal involvement
4. Pregnancy
Recruitment start date
01/04/1999
Recruitment end date
31/01/2002
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Public and Occupational Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Dutch Health Care Insurance Board (CVZ) (The Netherlands)
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
Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=14734329
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=16254756
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17186282
Publication citations
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Staal JB, Hlobil H, Twisk JW, Smid T, Köke AJ, van Mechelen W, Graded activity for low back pain in occupational health care: a randomized, controlled trial., Ann. Intern. Med., 2004, 140, 2, 77-84.
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Hlobil H, Staal JB, Twisk J, Köke A, Ariëns G, Smid T, van Mechelen W, The effects of a graded activity intervention for low back pain in occupational health on sick leave, functional status and pain: 12-month results of a randomized controlled trial., J Occup Rehabil, 2005, 15, 4, 569-580, doi: 10.1007/s10926-005-8035-y.
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Hlobil H, Uegaki K, Staal JB, de Bruyne MC, Smid T, van Mechelen W, Substantial sick-leave costs savings due to a graded activity intervention for workers with non-specific sub-acute low back pain., Eur Spine J, 2007, 16, 7, 919-924, doi: 10.1007/s00586-006-0283-9.