Protective Brace to Prevent Hand and Arm Injuries

Carpal Tunnel Syndrome Clinical Trial

Official title:

Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074893
• Other study ID #: NIAMS-079
• Secondary ID: 1R43AR049167-01
• Status: Completed
• Phase: N/A
• First received: December 23, 2003
• Last updated: March 6, 2006
• Start date: November 2003
• Est. completion date: February 2004

Study information

• Verified date: March 2006
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Cumulative Trauma Disorders

Intervention

Device:
• piezoelectric wrist brace

Locations

Country	Name	City	State
United States	UCLA Hand Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States,