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Protective Brace to Prevent Hand and Arm Injuries

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00074893
First received: December 23, 2003
Last updated: March 6, 2006
Last verified: March 2006
History of Changes

December 23, 2003
March 6, 2006
November 2003
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Complete list of historical versions of study NCT00074893 on ClinicalTrials.gov Archive Site
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Protective Brace to Prevent Hand and Arm Injuries
Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders

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.

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.
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Cumulative Trauma Disorders
  • Carpal Tunnel Syndrome
Device: piezoelectric wrist brace
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2004
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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
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074893
NIAMS-079, 1R43AR49167-01
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Michael D. Pottenger, PhD SmartWear, LLC
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP