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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 23, 2003 | ||||
| Last Updated Date | March 6, 2006 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00074893 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Protective Brace to Prevent Hand and Arm Injuries | ||||
| Official Title ICMJE | Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders | ||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: piezoelectric wrist brace | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00074893 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIAMS-079, 1R43AR49167-01 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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