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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR952 |
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Date of registration:
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19/04/2007 |
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Primary sponsor: |
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Public title:
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The Amsterdam Graded Activity Study.
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Scientific title:
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Graded activity for low back pain in occupational health: a randomized controlled trial. - AGAS |
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Date of first enrolment:
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1/4/1999 |
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Target sample size:
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134 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=952 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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W.
Mechelen, van |
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Address:
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VU Medical Center, Department of Social Medicine,
P.O. Box 7057 , De Boelelaan 1117
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4448410 |
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Email:
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w.vanmechelen@vumc.nl |
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Affiliation:
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Name:
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W.
Mechelen, van |
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Address:
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VU Medical Center, Department of Social Medicine,
P.O. Box 7057 , De Boelelaan 1117
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4448410 |
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Email:
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w.vanmechelen@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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 4 weeks in succession.
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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Low back pain (LBP), Sick leave, Pain, Occupational health, Physical exercise
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Intervention(s)
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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 3 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.
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Primary Outcome(s)
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1. Days of sick leave due to low back pain;
2. Disability;
3. Pain.
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Secondary Outcome(s)
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Pain-related fears.
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Secondary ID(s)
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ISRCTN46141261
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Source(s) of Monetary Support
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Dutch Health Care Insurance Board (CVZ, independent governement organisation)
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