Condition category
Musculoskeletal Diseases
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
21/09/2007
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. 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

http://www.vumc.nl/english/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes