Cumulative Trauma DisordersNCT00074893
Protective Brace to Prevent Hand and Arm Injuries
A study testing piezoelectric wrist brace in people with Cumulative Trauma Disorders and Carpal Tunnel Syndrome, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cumulative Trauma Disorders, Carpal Tunnel Syndrome
- What is being tested?
- piezoelectric wrist brace
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Feb 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal hand anatomy and full range of motion
Who cannot join
- History of significant hand or wrist arthritis
- Open wounds
- Prior hand or wrist surgery
- Neuropathies
- Skin hypersensitivity
- Contact dermatitis
- Reflex sympathetic dystrophy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Hand Center
Los Angeles, California, 90095-6902
About this study
Official title: 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.
Read the 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.
- Being tested
- piezoelectric wrist brace
- Keywords
- Repetitive Strain Injuries, Vibration Damping, Protective Brace, Piezoelectric, SmartWear
- Medical subject headings
- Cumulative Trauma Disorders, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezoelectric wrist braceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2003 (estimated)
- Study startNov 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cumulative Trauma DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael D. Pottenger, PhD, Principal investigator, SmartWear, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074893
- Sponsor's protocol ID
- NIAMS-079
- Other IDs
- 1R43AR049167-01
- Status last verified
- Mar 2006
- First submitted
- 23 Dec 2003
- Last updated
- 8 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT00074893
- Acronym / sponsor ID
- NIAMS-079
- Keywords
- Repetitive Strain Injuries, Vibration Damping, Protective Brace, Piezoelectric, SmartWear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Nov 2003
- Study completion
- Feb 2004
- First posted
- 24 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal hand anatomy and full range of motion
Key exclusion criteria (7 listed)
- History of significant hand or wrist arthritis
- Open wounds
- Prior hand or wrist surgery
- Neuropathies
- Skin hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piezoelectric wrist brace | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D. Pottenger, PhD principal investigator
SmartWear, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piezoelectric wrist brace in people with Cumulative Trauma Disorders and Carpal Tunnel Syndrome, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2006.