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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01178983
Other study ID # SHEBA-10-7334-RP-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received August 9, 2010
Last updated June 20, 2011
Start date August 2010
Est. completion date October 2011

Study information

Verified date June 2011
Source Sheba Medical Center
Contact Merav Golombowicz, BOT
Phone 035303723
Email meravgo2@post.tau.ac.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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).

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
surface electromyography
Surface electromyography (SEMG) telebiofeedback
surface electromyography
conventional biofeedback

Locations

Country Name City State
Israel Sheba Tel Hashomer hospital - upper limb rehabilitation center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Posture at work environment measured by Rapid Upper LImb Assessment (RULA) 15 months No
Secondary Musculoskeletal Disorders (MSD) - pain and inconvenience 15 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02676635 - Safety Voice for Ergonomics as a Preventive Approach for Work-related Musculoskeletal Disorders in Masonry Apprentices N/A