Status:
UNKNOWN
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Lead Sponsor:
Yuinvent Innovations Ltd.
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Interventional study to evaluate efficacy and safety of an active splint.
Eligibility Criteria
Inclusion
- Male or female patients, above 40 years of age.
- Able to understand and sign informed consent
- Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
- Numbness and tingling in the median nerve distribution
- Nocturnal Numbness
- Weakness and/or atrophy of the thenar musculature
- Demonstrate positive Phalen's Test of the affected extremity
- Demonstrate positive Tinel's Test of the affected extremity
- Sensory impairment defined as a loss of 2-point discrimination
- Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome
Exclusion
- • Currently receiving treatment for carpal tunnel syndrome
- History of surgical carpal tunnel release
- Pregnancy
- Diabetes not controlled by medication
- Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy
- Thoracic outlet syndrome
- Compromised skin integrity
- Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand
Key Trial Info
Start Date :
January 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03810326
Start Date
January 12 2019
End Date
January 1 2020
Last Update
January 18 2019
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel