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Effectiveness of Ergonomic Intervention

Primary Purpose

Low Back Pain, Neck Pain, Upper Extremity

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Ergonomic Intervention

About this trial

This is an interventional prevention trial for Low Back Pain focused on measuring Ergonomic intervention, Musculoskeletal disorders, Low back pain, Posture, Video display terminal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Bologna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Drawing with a Visual Analogue Scale

Full Information

NCT ID

NCT00791596

First Posted

November 13, 2008

Last Updated

November 13, 2008

Sponsor

University of Bologna

1. Study Identification

Unique Protocol Identification Number

NCT00791596

Brief Title

Effectiveness of Ergonomic Intervention

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 Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Bologna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Neck Pain, Upper Extremity, Lower Extremity

Keywords

Ergonomic intervention, Musculoskeletal disorders, Low back pain, Posture, Video display terminal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Ergonomic Intervention

Other Intervention Name(s)

Preventive Intervention of Musculoskeletal Disorders

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain Drawing with a Visual Analogue Scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paolo Pillastrini, MSc

Organizational Affiliation

University of Bologna

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Bologna

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

17405805

Citation

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.

Results Reference

result

PubMed Identifier

19853837

Citation

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.

Results Reference

derived

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Effectiveness of Ergonomic Intervention

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