Effectiveness of Ergonomic Intervention

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791596
• Other study ID #: PP001012008
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2008
• Last updated: November 13, 2008
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Extremity
• Neck Pain
• Upper Extremity

Intervention

Other:
• Ergonomic Intervention
The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design

Locations

Country	Name	City	State
Italy	University of Bologna	Bologna	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R.E.B.A. (Rapid Entire Body Assessment) method		Baseline, 6 months, 12 months, 30 months, 36 months	No
Secondary	Pain Drawing with a Visual Analogue Scale		Baseline, 6 months, 12 months, 30 months, 36 months	No