Condition category
Musculoskeletal Diseases
Date applied
21/08/2003
Date assigned
22/08/2003
Last edited
30/06/2009
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 Willem Van Mechelen

ORCID ID

Contact details

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8410
w.van_mechelen.emgo@med.vu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3140.0001

Study information

Scientific title

Acronym

ASE

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Non specific low back pain

Intervention

1. Participatory ergonomics
2. Graded activity
3. Usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/1999

Overall trial end date

01/10/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Workers on sick leave for 2 to 6 weeks due to non specific low back pain.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/01/1999

Recruitment end date

01/10/2002

Locations

Countries of recruitment

Netherlands

Trial participating centre

van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

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

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Ministries of Health, Welfare and Sports and of Social Affairs (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

1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14629775
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17268258
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19412140

Publication citations

  1. Protocol

    Steenstra IA, Anema JR, Bongers PM, de Vet HC, van Mechelen W, Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560]., BMC Musculoskelet Disord, 2003, 4, 26, doi: 10.1186/1471-2474-4-26.

  2. Results

    Anema JR, Steenstra IA, Bongers PM, de Vet HC, Knol DL, Loisel P, van Mechelen W, Multidisciplinary rehabilitation for subacute low back pain: graded activity or workplace intervention or both? A randomized controlled trial., Spine, 2007, 32, 3, 291-8; discussion 299-300, doi: 10.1097/01.brs.0000253604.90039.ad.

  3. Results

    Steenstra IA, Knol DL, Bongers PM, Anema JR, van Mechelen W, de Vet HC, What works best for whom? An exploratory, subgroup analysis in a randomized, controlled trial on the effectiveness of a workplace intervention in low back pain patients on return to work., Spine, 2009, 34, 12, 1243-1249, doi: 10.1097/BRS.0b013e3181a09631.

Additional files

Editorial Notes