Condition category
Musculoskeletal Diseases
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
03/01/2012
Prospective/Retrospective
Prospectively 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

Mr Maurice Driessen, MSc

ORCID ID

Contact details

EMGO-instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 1710
m.driessen@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Is the participatory ergonomics program for workers without back or neck pain in the previous year, effective in the prevention of back and/or neck pain.

Ethics approval

Approval received from the Medical Ethical Committee of the VU Medical Centre on the 1st January 2007.

Study design

Randomised placebo controlled parallel group multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Back and neck pain

Intervention

The intervention is a participative ergonomic program. The participative ergonomics apporoach is based on the active participation and strong commitment of the employer and employee in the process to identify (potential) risk factors in the workplace and to choose the most appropriate solutions for these risks. The program consists of six steps including a workplace observation, interviews and two meetings of one and five hours with (representatives of) workers and management from a department.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the incidence of back and/or neck pain in the year of follow-up, assessed by means of a postal questionnaire. In the baseline and follow-up questionnaires, data on the incidence of back and neck pain will be collected using an adapted version of the Nordic Questionnaire. Cases of back and/or neck pain will be defined as those workers who reported regular of prolonged back pain and/or neck pain in the previous 12 months.

Secondary outcome measures

Secondary outcome measures are:
1. Functional status
2. Pain intensity and sickness absence
3. Use of ergonomic measures

Data on sickness absence will be collected on the basis of company and occupational health services registers. With respect to the economic evaluation data related to direct and indirect costs (costs in paid and unpaid labor as a consequence of sick leave or disability) and quality of life will be collected

Overall trial start date

01/10/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Working more than 20 hours a week
2. More than one year employed

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3668

Participant exclusion criteria

Workers with back and or neck pain in the three months prior to the intervention will be excluded.

Recruitment start date

01/10/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

EMGO-instituut
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20735823
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21177661
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21499671

Publication citations

  1. Results

    Driessen MT, Proper KI, Anema JR, Bongers PM, van der Beek AJ, Process evaluation of a participatory ergonomics programme to prevent low back pain and neck pain among workers., Implement Sci, 2010, 5, 65, doi: 10.1186/1748-5908-5-65.

  2. Results

    Driessen MT, Proper KI, Anema JR, Knol DL, Bongers PM, van der Beek AJ, Participatory ergonomics to reduce exposure to psychosocial and physical risk factors for low back pain and neck pain: results of a cluster randomised controlled trial., Occup Environ Med, 2011, 68, 9, 674-681, doi: 10.1136/oem.2010.056739.

  3. Results

    Driessen MT, Proper KI, Anema JR, Knol DL, Bongers PM, van der Beek AJ, The effectiveness of participatory ergonomics to prevent low-back and neck pain--results of a cluster randomized controlled trial., Scand J Work Environ Health, 2011, 37, 5, 383-393, doi: 10.5271/sjweh.3163.

Additional files

Editorial Notes