Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators

NCT01562418 | Unknown

• 1 other identifier: 757-2008-IDF-CTIL
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Computer settings points to a number of risk factors which may induce the development of Work related MSD (WRMSD). In light of the expanded use of computers and the increased occurrence of Upper Extremity (UE) WRMSD among computer operators various intervention programs have been developed and tested. Nevertheless, many of these programs do not meet the criteria of quality and level of evidence. The main objective of this study is to use simultaneously a three dimensional (3D) kinematic analysis system, surface electromyography (SEMG) and fingertip force measurement system (Flexiforce) while typing, to test the efficacy of primary and secondary preventive intervention programs aimed at reducing MSD among computer operators. Work hypothesis: Significant score differences will be found on the evaluation parameters between the research group which underwent ergonomic training with biofeedback, the group without feedback, and the control group.The evaluated parameters will correlate with the appearance of MSD symptoms and pain and will affect level of function. The study will include 66 participants, programmers and computer engineers. The participants will be assigned randomly to one of three groups: 1) participants will receive ergonomic training with biofeedback; 2) participants will receive ergonomic training without biofeedback; and 3) control group, without intervention. Each group will consist of 22 participants. Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D kinematic measurements and fingertip forces relevant to typing while entering a standard text will be measured. At the work site, anthropometric and measurements, work station measurements, posture observation and questionnaires about, psychosocial status, function and pain level will be filled The preventive program will be performed at the workstation after the preliminary data collection phase. The program will consist of one group meeting at the workplace for all employees participating in the study, and individual instruction at the workstation, including 3-6 meetings for the two research groups. Data will be collected before and after the intervention program.

Conditions

Musculoskeletal Disorders; Upper Extremity Pain Chronic

Keywords

Ergonomics; musculoskeletal symptoms; kinematics

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal disorders measurement (MSD score)

  The MSD score of the whole body will be collected out of a self administrated questionnaire in the first meeting before intervention and in the last meeting. the score indicates the number of painful body regions that were harmful in the last week before answering the Questionnaire. Negative differences between post and pre intervention will indicate improvement in pain.

  Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

Secondary Outcomes (4)

• Rapid Upper Limb Assessment (RULA)score

  Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one

• Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.

  Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

• Muscle activity

  Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

• Psychosocial job characteristics assessment (DCSQ)

  Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

Study Arms (3)

Ergonomic consulting

EXPERIMENTAL

Ergonomic consulting without biofeedback

Behavioral: Standard ergonomic intervention

Ergonomic consulting with biofeedback

EXPERIMENTAL

Ergonomic intervention with biofeedback

Behavioral: Ergonomic intervention

general instructions

NO INTERVENTION

general instructions with no intervention

Behavioral: control group

Interventions

Ergonomic intervention BEHAVIORAL

Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)

Also known as: intervention no.2

Ergonomic consulting with biofeedback

Standard ergonomic intervention BEHAVIORAL

Standard ergonomic intervention , how to sit and work with computers

Also known as: intervention no 1

Ergonomic consulting

control group BEHAVIORAL

general instructions no intervention

Also known as: intervention 3

general instructions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• subjects working more than four hours per day in front of a computer and are right-hand dominant.
• Healthy or suffering from diagnoses of UE-MSD. (e.g. Rotator cuff syndrome , Lateral epicondylitis, Cubital tunnel syndrome, Carpal tunnel syndrome, Flexor-extensor peri-tendinitis or teno-synovitis of the forearm-wrist region, De Quervain's disease and Nonspecific MSD

You may not qualify if:

• Participants suffering from orthopedic injury or neurological deficit (with the exception of the diagnosis mentioned above).
• Medical conditions that cause swelling of the joints or hand numbness (pregnancy, diabetes, heart condition, arthritis).

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead

Study Sites (1)

Motion Laboratory, Sheba medical center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yafi Levanon, MsC

  Sheba Medical Center , Tel aviv University

  STUDY DIRECTOR

Central Study Contacts

Yafi Levanon, MSc

CONTACT

++972-52-6666598; yafil@post.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: March 23, 2012
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

IL (1)