Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01178983
First received: August 9, 2010
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Work Related Musculoskeletal Disorders
Device: surface electromyography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Posture at work environment measured by Rapid Upper LImb Assessment (RULA) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Musculoskeletal Disorders (MSD) - pain and inconvenience [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telebiofeedback Device: surface electromyography
Surface electromyography (SEMG) telebiofeedback
Active Comparator: biofeedback Device: surface electromyography
conventional biofeedback

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178983

Contacts
Contact: Merav Golombowicz, BOT 035303723 meravgo2@post.tau.ac.il

Locations
Israel
Sheba Tel Hashomer hospital - upper limb rehabilitation center Recruiting
Ramat Gan, Israel, 52621
Contact: merav golombowicz    035303723    meravgo@post.tau.ac.il   
Principal Investigator: yafi levanon, Phd         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Merav Golombowicz, BOT Upper Limb Rehabilitation Center
  More Information

No publications provided

Responsible Party: Merav Golombowicz, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01178983     History of Changes
Other Study ID Numbers: SHEBA-10-7334-RP-CTIL
Study First Received: August 9, 2010
Last Updated: June 20, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
work related musculoskeletal disorders (WRMSD) among computer operators

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014