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

22 maart 2012 bijgewerkt door: Medical Corps, Israel Defense Force

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

108

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Israël
      • Ramat Gan, Israël
        • Werving
        • Motion Laboratory, Sheba medical center
        • Hoofdonderzoeker:
          • Uri givon, MD
        • Contact:
        • Hoofdonderzoeker:
          • Ron Frimer, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ergonomic consulting
Ergonomic consulting without biofeedback
Gedragsmatig: Standard ergonomic intervention
Standard ergonomic intervention , how to sit and work with computers
Andere namen:
  • intervention no 1
Experimenteel: Ergonomic consulting with biofeedback
Ergonomic intervention with biofeedback
Gedragsmatig: Ergonomic intervention
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Andere namen:
  • intervention no.2
Geen tussenkomst: general instructions
general instructions with no intervention
Gedragsmatig: control group
general instructions no intervention
Andere namen:
  • intervention 3

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Musculoskeletal disorders measurement (MSD score)
Tijdsspanne: 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.
Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rapid Upper Limb Assessment (RULA)score
Tijdsspanne: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one
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
Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.
Tijdsspanne: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.
Muscle activity
Tijdsspanne: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.
Psychosocial job characteristics assessment (DCSQ)
Tijdsspanne: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medical Corps, Israel Defense Force

Onderzoekers

  • Studie directeur: Yafi Levanon, MsC, Sheba Medical Center , Tel aviv University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2009

Primaire voltooiing (Verwacht)

1 maart 2012

Studie voltooiing (Verwacht)

1 februari 2013

Studieregistratiedata

Eerst ingediend

14 juli 2011

Eerst ingediend dat voldeed aan de QC-criteria

22 maart 2012

Eerst geplaatst (Schatting)

23 maart 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

23 maart 2012

Laatste update ingediend die voldeed aan QC-criteria

22 maart 2012

Laatst geverifieerd

1 maart 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 757-2008-IDF-CTIL

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