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Effectiveness of Ergonomic Intervention

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ClinicalTrials.gov Identifier: NCT00791596
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
University of Bologna

Study Description
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Brief Summary:
This Research study aims to investigate the long term effectiveness of a workstation ergonomic intervention for work-related posture and low back pain (LBP) of Video Display Terminal (VDT) workers

Condition or disease Intervention/treatment Phase
Low Back Pain Neck Pain Upper Extremity Lower Extremity Other: Ergonomic Intervention Phase 4

Detailed Description:

A non-randomized, crossover trial design was used with follow-up repeated 6, 12, and 30 months from baseline in the first intervention period and then beginning at 6 months following the crossover.

The administrative offices in the two main buildings of the town hall of Forlì, Italy.

The study population was composed of 400 employees, who used VDTs for at least 20 hours a week, of whom we randomly selected 100 participants from each building. Of the 200 initial participants, 153 completed the study; the dropouts were due to illness/injury or maternity.

Participants were assigned to intervention or control during the first period and then crossed over after a 30-month washout. The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design.

Our study showed that the workstation ergonomic adjustment improved work-related posture and in reducing LBP in VDT operators among subjects who received the intervention both in the first period and in the crossover, and maintained these positive effects for at least 30 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of an Ergonomic Intervention on Work-Related Posture and Low Back Pain in Video Display Terminal Operators: a 3 Year Cross-Over Trial
Study Start Date : January 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
The first Arm received the intervention between baseline and the first follow-up, whereas the second Arm was the Control group
 Other: Ergonomic Intervention
The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design
Other Name: Preventive Intervention of Musculoskeletal Disorders
Experimental: 2
The second Arm received the intervention between the third and the fourth follow-up, whereas the first Arm was the Control group
 Other: Ergonomic Intervention
The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design
Other Name: Preventive Intervention of Musculoskeletal Disorders


Outcome Measures
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Primary Outcome Measures :
  1. R.E.B.A. (Rapid Entire Body Assessment) method [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ]

Secondary Outcome Measures :
  1. Pain Drawing with a Visual Analogue Scale [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study population was composed of 400 employees, who used VDTs for at least 20 hours a week

Exclusion Criteria:

  • Subjects were excluded if pregnant or had a medical history of serious injury, spinal surgery, malignant pathology, or severe disability
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791596


Locations
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Italy
University of Bologna
Bologna, Emilia-Romagna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Paolo Pillastrini, MSc University of Bologna
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paolo Pillastrini, University of Bologna
ClinicalTrials.gov Identifier: NCT00791596    
Other Study ID Numbers: PP001012008
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: October 2008
Keywords provided by University of Bologna:
Ergonomic intervention
Musculoskeletal disorders
Low back pain
Posture
Video display terminal
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neck Pain
Pain
Neurologic Manifestations