Condition category
Musculoskeletal Diseases
Date applied
19/06/2006
Date assigned
04/08/2006
Last edited
14/09/2011
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

Dr Vincent Hildebrandt

ORCID ID

Contact details

P.O. Box 2215
Leiden
2301 CE
Netherlands
+31 71 5181744
vh.hildebrandt@pg.tno.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WC 2002-044

Study information

Scientific title

Acronym

RSI@Work study

Study hypothesis

A lifestyle physical activity intervention has an added value in addition to a work style intervention focused on ergonomics, breaks and coping with high work demands on the recovery from neck and upper limb symptoms in computer workers.

Ethics approval

The study was approved by the medical ethics committee of the VU University Medical Center (07/09/2004), protocol number 2004/027.

Study design

Randomised controlled trial with two intervention groups and a control group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Neck and upper limb symptoms

Intervention

The interventions for the two intervention groups both consist of six group meetings in a six month period that take place at the workplace, during work time and under the supervision of a specially trained counsellor. In both intervention groups the goal of the group meetings is to improve workplace ergonomics, the number and quality of breaks and coping behaviour with regard to high work demands. In the work style and physical activity group the additional goal is to increase moderate to heavy physical activity. Both intervention groups are compared with a control group that does not receive any advice.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Degree of recovery
2. Pain intensity
3. Disability
4. Presence and number of days with neck and upper limb symptoms
5. Number of months without neck and upper limb symptoms

Secondary outcome measures

1. Physical activity
2. Body posture and workplace ergonomics
3. The use of breaks and exercise reminder software
4. Extrinsic effort and reward
5. Decision authority
6. Phase of behavioral change with regard to physical activity and work style
7. Cardiorespiratory fitness
8. Maximum grip strength
9. Absenteeism
10. Worker productivity

Overall trial start date

01/10/2002

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Computer workers aged 18-64
2. Frequent or long-term neck and upper limb symptoms in the preceding six months
3. Frequent or long-term neck and upper limb symptoms in the preceding two weeks

By using a six month period and a two week period, we intend to include workers with chronic and recurrent symptoms as well as workers with recent symptoms.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

405 computer workers with neck and upper limb symptoms

Participant exclusion criteria

1. Performing computer work at less than three days a week or during less than three hours a day
2. A working contract shorter than one year
3. Under care of a doctor or (physical) therapist for complaints in the neck, shoulders arms, wrists and/or hands
4. Non-work related pathologies or clear somatic afflictions (e.g. rheumatoid arthritis, cervical hernia, tennis elbow, carpal tunnel syndrome)
5. Sickness absence of 50% or more
6. Pregnant

Recruitment start date

01/10/2002

Recruitment end date

01/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

P.O. Box 2215
Leiden
2301 CE
Netherlands

Sponsor information

Organisation

Institute for Research in Extramural Medicine (The Netherlands)

Sponsor details

Research Center Physical Activity
Work and Health
TNO-VUmc
VU University Medical Center
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+ 31 20 4448206
i.vanderleden@vumc.nl

Sponsor type

Research organisation

Website

http://www.bodyatwork.nl

Funders

Funder type

Research organisation

Funder name

Institute for Research in Extramural Medicine of the VU University Medical Center (EMGO-institute) and TNO Quality of Life (Netherlands). The study is internally funded.

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. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17062141
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17768009
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20864468

Publication citations

  1. Protocol

    Bernaards CM, Ariëns GA, Hildebrandt VH, The (cost-)effectiveness of a lifestyle physical activity intervention in addition to a work style intervention on the recovery from neck and upper limb symptoms in computer workers., BMC Musculoskelet Disord, 2006, 7, 80, doi: 10.1186/1471-2474-7-80.

  2. Results

    Bernaards CM, Ariëns GA, Knol DL, Hildebrandt VH, The effectiveness of a work style intervention and a lifestyle physical activity intervention on the recovery from neck and upper limb symptoms in computer workers., Pain, 2007, 132, 1-2, 142-153, doi: 10.1016/j.pain.2007.06.007.

  3. Results

    Bernaards CM, Bosmans JE, Hildebrandt VH, van Tulder MW, Heymans MW, The cost-effectiveness of a lifestyle physical activity intervention in addition to a work style intervention on recovery from neck and upper limb symptoms and pain reduction in computer workers., Occup Environ Med, 2011, 68, 4, 265-272, doi: 10.1136/oem.2008.045450.

Additional files

Editorial Notes