Effectiveness of Ergonomic Intervention

This study has been completed.
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00791596
First received: November 13, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention Phase
Low Back Pain
Neck Pain
Upper Extremity
Lower Extremity
Other: Ergonomic Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • R.E.B.A. (Rapid Entire Body Assessment) method [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Drawing with a Visual Analogue Scale [ Time Frame: Baseline, 6 months, 12 months, 30 months, 36 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00791596

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Pillastrini, University of Bologna
ClinicalTrials.gov Identifier: NCT00791596     History of Changes
Other Study ID Numbers: PP001012008
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
Ergonomic intervention
Musculoskeletal disorders
Low back pain
Posture
Video display terminal

Additional relevant MeSH terms:
Back Pain
Neck Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014