Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Not Applicable
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Device: CTR device (tradename named Xtend)
- Registration Number
- NCT03810326
- Lead Sponsor
- Yuinvent Innovations Ltd.
- Brief Summary
Interventional study to evaluate efficacy and safety of an active splint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention CTR device (tradename named Xtend) -
- Primary Outcome Measures
Name Time Method Reduction in pain score 10 weeks Reduction in NRS reported pain score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel