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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Medical Corps, Israel Defense Force.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01562418
First received: July 14, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Musculoskeletal Disorders
Upper Extremity Pain Chronic
Behavioral: Ergonomic intervention
Behavioral: Standard ergonomic intervention
Behavioral: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators

Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • Musculoskeletal disorders measurement (MSD score) [ Time Frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rapid Upper Limb Assessment (RULA)score [ Time Frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one ] [ Designated as safety issue: No ]
    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.

  • Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system. [ Time Frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. ] [ Designated as safety issue: No ]
    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.

  • Muscle activity [ Time Frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. ] [ Designated as safety issue: No ]
    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.

  • Psychosocial job characteristics assessment (DCSQ) [ Time Frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 108
Study Start Date: September 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergonomic consulting
Ergonomic consulting without biofeedback
Behavioral: Standard ergonomic intervention
Standard ergonomic intervention , how to sit and work with computers
Other Name: intervention no 1
Experimental: Ergonomic consulting with biofeedback
Ergonomic intervention with biofeedback
Behavioral: Ergonomic intervention
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Other Name: intervention no.2
No Intervention: general instructions
general instructions with no intervention
Behavioral: control group
general instructions no intervention
Other Name: intervention 3

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562418

Contacts
Contact: Yafi Levanon, MSc ++972-52-6666598 yafil@post.tau.ac.il

Locations
Israel
Motion Laboratory, Sheba medical center Recruiting
Ramat Gan, Israel
Contact: Yafi Levanon, MSc    ++972-52- 6666598    yafil@post.tau.ac.il   
Principal Investigator: Uri givon, MD         
Principal Investigator: Ron Frimer, MD         
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Study Director: Yafi Levanon, MsC Sheba Medical Center , Tel aviv University
  More Information

No publications provided

Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01562418     History of Changes
Other Study ID Numbers: 757-2008-IDF-CTIL
Study First Received: July 14, 2011
Last Updated: March 22, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Medical Corps, Israel Defense Force:
Ergonomics
musculoskeletal symptoms
kinematics

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014