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

22. marts 2012 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

108

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Ramat Gan, Israel
        • Rekruttering
        • Motion Laboratory, Sheba medical center
        • Ledende efterforsker:
          • Uri givon, MD
        • Kontakt:
        • Ledende efterforsker:
          • Ron Frimer, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ergonomic consulting
Ergonomic consulting without biofeedback
Standard ergonomic intervention , how to sit and work with computers
Andre navne:
  • intervention no 1
Eksperimentel: Ergonomic consulting with biofeedback
Ergonomic intervention with biofeedback
Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
Andre navne:
  • intervention no.2
Ingen indgriben: general instructions
general instructions with no intervention
general instructions no intervention
Andre navne:
  • intervention 3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Musculoskeletal disorders measurement (MSD score)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rapid Upper Limb Assessment (RULA)score
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2009

Primær færdiggørelse (Forventet)

1. marts 2012

Studieafslutning (Forventet)

1. februar 2013

Datoer for studieregistrering

Først indsendt

14. juli 2011

Først indsendt, der opfyldte QC-kriterier

22. marts 2012

Først opslået (Skøn)

23. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 757-2008-IDF-CTIL

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