Musculoskeletal DisordersNCT01562418
Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
A study testing Ergonomic intervention and Standard ergonomic intervention in people with Musculoskeletal Disorders and Upper Extremity Pain Chronic, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders, Upper Extremity Pain Chronic
- What is being tested?
- Ergonomic intervention and Standard ergonomic intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Motion Laboratory, Sheba medical center
Ramat Gan
Yafi Levanon, MSc, ++972-52- 6666598, yafil@post.tau.ac.il
Uri givon, MD
About this study
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.
Read more
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.
- Being tested
- Ergonomic intervention, Standard ergonomic intervention, control group
- Keywords
- Ergonomics, musculoskeletal symptoms, kinematics
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic interventionBehavioural
Also called intervention no.2
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Standard ergonomic interventionBehavioural
Also called intervention no 1
Standard ergonomic intervention , how to sit and work with computers
control groupBehavioural
Also called intervention 3
general instructions no intervention
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic consulting | Experimental | Ergonomic consulting without biofeedback Receives: Behavioral: Standard ergonomic intervention |
| Ergonomic consulting with biofeedback | Experimental | Ergonomic intervention with biofeedback Receives: Behavioral: Ergonomic intervention |
| general instructions | No intervention | general instructions with no intervention Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Secondary outcomes (4)
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.
Measured: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
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.
Measured: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.
Measured: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.
Measured: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionMar 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yafi Levanon, MsC, Study director, Sheba Medical Center , Tel aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562418
- Sponsor's protocol ID
- 757-2008-IDF-CTIL
- Status last verified
- Mar 2012
- First submitted
- 14 Jul 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators
- ClinicalTrials.gov ID
- NCT01562418
- Acronym / sponsor ID
- 757-2008-IDF-CTIL
- Keywords
- Ergonomics, musculoskeletal symptoms, kinematics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ergonomic consulting | Experimental | Behavioral: Standard ergonomic interventionErgonomic consulting without biofeedback |
| Ergonomic consulting with biofeedback | Experimental | Behavioral: Ergonomic interventionErgonomic intervention with biofeedback |
| general instructions | No intervention | Behavioral: control groupgeneral instructions with no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic interventionAlso: intervention no.2Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback) | Behavioural | Ergonomic consulting with biofeedback |
| Standard ergonomic interventionAlso: intervention no 1Standard ergonomic intervention , how to sit and work with computers | Behavioural | Ergonomic consulting |
| control groupAlso: intervention 3general instructions no intervention | Behavioural | general instructions |
Primary outcome
Musculoskeletal disorders measurement (MSD score)
Time frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.
4 secondary outcomes
Rapid Upper Limb Assessment (RULA)score
Time frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
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.
Muscle activity
Time frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Psychosocial job characteristics assessment (DCSQ)
Time frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yafi Levanon, MsC study director
Sheba Medical Center , Tel aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic intervention and Standard ergonomic intervention in people with Musculoskeletal Disorders and Upper Extremity Pain Chronic, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yafi Levanon, MSc (++972-52-6666598, yafil@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal disorders measurement (MSD score) (time frame: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012; AzTrials last refreshed its copy on 28 Oct 2026.