Musculoskeletal Disorders Clinical Trial
Official title:
Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
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.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | February 2013 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Israel | Motion Laboratory, Sheba medical center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Medical Corps, Israel Defense Force |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | Rapid Upper Limb Assessment (RULA)score | The RULA is an observation that assess the posture at work. The assessment will be held in the work place in the first meeting before intervention and in the last meeting. The score ranged between 0-7, higher score indicates higher risk for MSD. Negative differences between post and pre intervention will indicate improvement in posture at work. | Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one | No |
Secondary | Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system. | The Kinematics of the upper extremity (fingers, wrist and elbow) will be measured in the second and in the last meeting at the motion laboratory. The second meeting will be not more than 2 weeks after the first meeting.R.O.M will be measured in degrees and the angular velocity will be presented in degrees per seconds. .Negative differences between post and pre intervention indicates improvement in R.O.M and angular velocity. | Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. | No |
Secondary | Muscle activity | The muscle activity amplitude of the wrist and finger extensors and the upper trapezius will be measured and collected in the second meeting at the motion laboratory simultaneously with the kinematic data.The muscle amplitude will be presented as percentile of the Maximal Voluntary Contraction (MVC) of the same muscles. Higher percentage of muscle activity will indicate higher muscle load. Negative differences between post and pre intervention indicates improvement in muscle activity. | Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. | No |
Secondary | Psychosocial job characteristics assessment (DCSQ) | The D.C.S.Q will be measured by a self administrated questionnaire in the first meeting before intervention and in the last meeting. The job demands score range between 5-25 and the decision latitude score range between 8-40. Low level of job demands and high decision latitude indicates low level of stress at work. | Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. | No |
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