Clinical trial NCT01562418: Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
Official title: Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Disorders
Upper Extremity Pain Chronic
Keywords: Ergonomics
musculoskeletal symptoms
kinematics
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Musculoskeletal disorders measurement (MSD score)
timeFrame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Secondary outcomes:
measure: Rapid Upper Limb Assessment (RULA)score
timeFrame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
measure: Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.
timeFrame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
measure: Muscle activity
timeFrame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
measure: Psychosocial job characteristics assessment (DCSQ)
timeFrame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Motion Laboratory, Sheba medical center
Study officials:
affiliation: Sheba Medical Center , Tel aviv University
name: Yafi Levanon, MsC
role: STUDY_DIRECTOR
References: