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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00791596
Other study ID # PP001012008
Secondary ID
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


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
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