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

NCT ID: NCT01562418

Last Updated: 2012-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ergonomic consulting

Ergonomic consulting without biofeedback

Group Type: EXPERIMENTAL

Standard ergonomic intervention

Intervention Type: BEHAVIORAL

Standard ergonomic intervention , how to sit and work with computers

Ergonomic consulting with biofeedback

Ergonomic intervention with biofeedback

Group Type: EXPERIMENTAL

Ergonomic intervention

Intervention Type: BEHAVIORAL

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

general instructions

general instructions with no intervention

Group Type: NO_INTERVENTION

control group

Intervention Type: BEHAVIORAL

general instructions no intervention

Interventions

Ergonomic intervention

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

Intervention Type: BEHAVIORAL

Standard ergonomic intervention

Standard ergonomic intervention , how to sit and work with computers

Intervention Type: BEHAVIORAL

control group

general instructions no intervention

Intervention Type: BEHAVIORAL

Other Intervention Names

intervention no.2; intervention no 1; intervention 3

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Corps, Israel Defense Force

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yafi Levanon, MsC

Role: STUDY_DIRECTOR

Sheba Medical Center , Tel aviv University

Locations

Motion Laboratory, Sheba medical center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yafi Levanon, MSc

Role: CONTACT

yafil@post.tau.ac.il

++972-52-6666598

Facility Contacts

Yafi Levanon, MSc

Role: primary

yafil@post.tau.ac.il

++972-52- 6666598

Other Identifiers

757-2008-IDF-CTIL

Identifier Type: -

Identifier Source: org_study_id