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Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators

Primary Purpose

Work Related Musculoskeletal Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
surface electromyography
surface electromyography
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Work Related Musculoskeletal Disorders focused on measuring work related musculoskeletal disorders (WRMSD) among computer operators

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Sheba Tel Hashomer hospital - upper limb rehabilitation centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

telebiofeedback

biofeedback

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Musculoskeletal Disorders (MSD) - pain and inconvenience

Full Information

First Posted
August 9, 2010
Last Updated
June 20, 2011
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01178983
Brief Title
Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Related Musculoskeletal Disorders
Keywords
work related musculoskeletal disorders (WRMSD) among computer operators

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telebiofeedback
Arm Type
Experimental
Arm Title
biofeedback
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
surface electromyography
Intervention Description
Surface electromyography (SEMG) telebiofeedback
Intervention Type
Device
Intervention Name(s)
surface electromyography
Intervention Description
conventional biofeedback
Primary Outcome Measure Information:
Title
Posture at work environment measured by Rapid Upper LImb Assessment (RULA)
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Musculoskeletal Disorders (MSD) - pain and inconvenience
Time Frame
15 months

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: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merav Golombowicz, BOT
Phone
035303723
Email
meravgo2@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merav Golombowicz, BOT
Organizational Affiliation
Upper Limb Rehabilitation Center
Official's Role
Study Chair
Facility Information:
Facility Name
Sheba Tel Hashomer hospital - upper limb rehabilitation center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
merav golombowicz
Phone
035303723
Email
meravgo@post.tau.ac.il
First Name & Middle Initial & Last Name & Degree
yafi levanon, Phd

12. IPD Sharing Statement

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Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators

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