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

Primary Purpose

Musculoskeletal Disorders, Upper Extremity Pain Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ergonomic intervention
Standard ergonomic intervention
control group
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Disorders focused on measuring Ergonomics, musculoskeletal symptoms, kinematics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Motion Laboratory, Sheba medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ergonomic consulting

Ergonomic consulting with biofeedback

general instructions

Arm Description

Ergonomic consulting without biofeedback

Ergonomic intervention with biofeedback

general instructions with no intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 14, 2011
Last Updated
March 22, 2012
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT01562418
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Corps, Israel Defense Force

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders, Upper Extremity Pain Chronic
Keywords
Ergonomics, musculoskeletal symptoms, kinematics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ergonomic consulting
Arm Type
Experimental
Arm Description
Ergonomic consulting without biofeedback
Arm Title
Ergonomic consulting with biofeedback
Arm Type
Experimental
Arm Description
Ergonomic intervention with biofeedback
Arm Title
general instructions
Arm Type
No Intervention
Arm Description
general instructions with no intervention
Intervention Type
Behavioral
Intervention Name(s)
Ergonomic intervention
Other Intervention Name(s)
intervention no.2
Intervention Description
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Intervention Type
Behavioral
Intervention Name(s)
Standard ergonomic intervention
Other Intervention Name(s)
intervention no 1
Intervention Description
Standard ergonomic intervention , how to sit and work with computers
Intervention Type
Behavioral
Intervention Name(s)
control group
Other Intervention Name(s)
intervention 3
Intervention Description
general instructions no intervention
Primary Outcome Measure Information:
Title
Musculoskeletal disorders measurement (MSD score)
Description
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.
Time Frame
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Secondary Outcome Measure Information:
Title
Rapid Upper Limb Assessment (RULA)score
Description
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.
Time Frame
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
Title
Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.
Description
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.
Time Frame
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Title
Muscle activity
Description
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.
Time Frame
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Title
Psychosocial job characteristics assessment (DCSQ)
Description
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.
Time Frame
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yafi Levanon, MSc
Phone
++972-52-6666598
Email
yafil@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yafi Levanon, MsC
Organizational Affiliation
Sheba Medical Center , Tel aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Motion Laboratory, Sheba medical center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yafi Levanon, MSc
Phone
++972-52- 6666598
Email
yafil@post.tau.ac.il
First Name & Middle Initial & Last Name & Degree
Uri givon, MD
First Name & Middle Initial & Last Name & Degree
Ron Frimer, MD

12. IPD Sharing Statement

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

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