NCT01178983

Brief Summary

In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has been found that many musculoskeletal disorders are connected, among others, to biomechanical and psychosocial factors relating to a person's work environment, the literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive motions, awkward positions or static muscle loading over prolonged periods of time, use of high keystroke force, direct mechanical pressure, vibration and extreme temperatures. Computer operators found to be sitting statically for a long time in front of the computer and keyboard, with limited options of changing body position. Psychosocial factors have also been implicated in the workstation musculoskeletal disorders with computer operators. Workers with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore, it may include changes in the employment and earnings for injured workers. The complex nature of these injuries suggests that workplace rehabilitation interventions are a crucial aspect of treatment management. The main objective of this study is to explore the use of biofeedback intervention, based on tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be done by ANOVA Repeated Measures. Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found effective with computer operators suffer from WRMSD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

August 9, 2010

Last Update Submit

June 20, 2011

Conditions

Keywords

work related musculoskeletal disorders (WRMSD) among computer operators

Outcome Measures

Primary Outcomes (1)

  • Posture at work environment measured by Rapid Upper LImb Assessment (RULA)

    15 months

Secondary Outcomes (1)

  • Musculoskeletal Disorders (MSD) - pain and inconvenience

    15 months

Study Arms (2)

telebiofeedback

EXPERIMENTAL
Device: surface electromyography

biofeedback

ACTIVE COMPARATOR
Device: surface electromyography

Interventions

Surface electromyography (SEMG) telebiofeedback

telebiofeedback

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • computer operators who spend more than 4 hours a day working with computer
  • computer operators who suffer from pain and inconvenience or injury in upper limbs, such as Lateral Epicondylitis, de Quervain disease, Carpal Tunnel Syndrome (CTS), Ulnar Tunnel Syndrome, Flexor-Extensor peritendinitis or teno-synovitis of the forearm-wrist region.

You may not qualify if:

  • subjects who suffer from neurological injuries
  • subjects who suffer from orthopedic injuries or other metabolic or autoimmune diseases, that cause joint oedema or hand numbness (pregnancy, diabetes, heart disease and arthritis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Tel Hashomer hospital - upper limb rehabilitation center

Ramat Gan, Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Interventions

Electromyography

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Merav Golombowicz, BOT

    Upper Limb Rehabilitation Center

    STUDY CHAIR

Central Study Contacts

Merav Golombowicz, BOT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations