Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

Not Applicable

• Conditions: Carpal Tunnel Syndrome

• 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

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-12
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Posted: 2019-01-18
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

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

Primary Outcome Measures

Name	Time	Method
Reduction in pain score	10 weeks	Reduction in NRS reported pain score

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel