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Protective Brace to Prevent Hand and Arm Injuries

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074893
First Posted: December 24, 2003
Last Update Posted: March 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  Purpose
When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

Condition Intervention
Cumulative Trauma Disorders Carpal Tunnel Syndrome Device: piezoelectric wrist brace

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 15
Study Start Date: November 2003
Estimated Study Completion Date: February 2004
Detailed Description:

Workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of occupational MSDs. The National Institute for Occupational Safety and Health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. Most currently available braces do not adequately address these NIOSH requirements. This study will evaluate the efficacy of a brace with piezoelectric damping material.

Participants in the study will be fitted with a brace on each hand. One brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. Participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. The tests will take approximately 30 minutes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal hand anatomy and full range of motion

Exclusion Criteria:

  • History of significant hand or wrist arthritis
  • Open wounds
  • Prior hand or wrist surgery
  • Neuropathies
  • Skin hypersensitivity
  • Contact dermatitis
  • Reflex sympathetic dystrophy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074893


Locations
United States, California
UCLA Hand Center
Los Angeles, California, United States, 90095-6902
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Michael D. Pottenger, PhD SmartWear, LLC
  More Information

ClinicalTrials.gov Identifier: NCT00074893     History of Changes
Other Study ID Numbers: NIAMS-079
1R43AR049167-01 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2003
First Posted: December 24, 2003
Last Update Posted: March 8, 2006
Last Verified: March 2006

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Repetitive Strain Injuries
Vibration Damping
Protective Brace
Piezoelectric
SmartWear

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Cumulative Trauma Disorders
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries