Clinical trial NCT00791596: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Neck Pain
Upper Extremity
Lower Extremity
Keywords: Ergonomic intervention
Musculoskeletal disorders
Low back pain
Posture
Video display terminal
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: R.E.B.A. (Rapid Entire Body Assessment) method
timeFrame: Baseline, 6 months, 12 months, 30 months, 36 months
Secondary outcomes:
measure: Pain Drawing with a Visual Analogue Scale
timeFrame: Baseline, 6 months, 12 months, 30 months, 36 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia-Romagna
Study officials:
affiliation: University of Bologna
name: Paolo Pillastrini, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.