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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

Tracking Information
First Submitted Date  ICMJE November 13, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date November 14, 2008
Study Start Date  ICMJE January 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
R.E.B.A. (Rapid Entire Body Assessment) method [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Pain Drawing with a Visual Analogue Scale [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ergonomic Intervention
Official Title  ICMJE Effectiveness of an Ergonomic Intervention on Work-Related Posture and Low Back Pain in Video Display Terminal Operators: a 3 Year Cross-Over Trial
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Low Back Pain
  • Neck Pain
  • Upper Extremity
  • Lower Extremity
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 1
    The first Arm received the intervention between baseline and the first follow-up, whereas the second Arm was the Control group
    Intervention: Other: Ergonomic Intervention
  • Experimental: 2
    The second Arm received the intervention between the third and the fourth follow-up, whereas the first Arm was the Control group
    Intervention: Other: Ergonomic Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2008)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791596
Other Study ID Numbers  ICMJE PP001012008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paolo Pillastrini, University of Bologna
Study Sponsor  ICMJE University of Bologna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Pillastrini, MSc University of Bologna
PRS Account University of Bologna
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP