NCT00791596

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 low-back-pain

Timeline
Completed

Started Jan 2005

Typical duration for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
Last Updated

November 14, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

November 13, 2008

Last Update Submit

November 13, 2008

Conditions

Keywords

Ergonomic interventionMusculoskeletal disordersLow back painPostureVideo display terminal

Outcome Measures

Primary Outcomes (1)

  • R.E.B.A. (Rapid Entire Body Assessment) method

    Baseline, 6 months, 12 months, 30 months, 36 months

Secondary Outcomes (1)

  • Pain Drawing with a Visual Analogue Scale

    Baseline, 6 months, 12 months, 30 months, 36 months

Study Arms (2)

1

EXPERIMENTAL

The first Arm received the intervention between baseline and the first follow-up, whereas the second Arm was the Control group

Other: Ergonomic Intervention

2

EXPERIMENTAL

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

Interventions

The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design

Also known as: Preventive Intervention of Musculoskeletal Disorders
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects were excluded if pregnant or had a medical history of serious injury, spinal surgery, malignant pathology, or severe disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (2)

  • Pillastrini P, Mugnai R, Farneti C, Bertozzi L, Bonfiglioli R, Curti S, Mattioli S, Violante FS. Evaluation of two preventive interventions for reducing musculoskeletal complaints in operators of video display terminals. Phys Ther. 2007 May;87(5):536-44. doi: 10.2522/ptj.20060092. Epub 2007 Apr 3.

  • Pillastrini P, Mugnai R, Bertozzi L, Costi S, Curti S, Guccione A, Mattioli S, Violante FS. Effectiveness of an ergonomic intervention on work-related posture and low back pain in video display terminal operators: a 3 year cross-over trial. Appl Ergon. 2010 May;41(3):436-43. doi: 10.1016/j.apergo.2009.09.008. Epub 2009 Oct 23.

MeSH Terms

Conditions

Low Back PainNeck PainMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paolo Pillastrini, MSc

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

January 1, 2005

Primary Completion

June 1, 2005

Study Completion

December 1, 2007

Last Updated

November 14, 2008

Record last verified: 2008-10

Locations