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

Yuinvent Innovations Ltd.1 site in 1 country40 target enrollmentJanuary 12, 2019

Overview

Interventional study to evaluate efficacy and safety of an active splint.

Registry

clinicaltrials.gov

Start Date

January 12, 2019

End Date

January 1, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Yuinvent Innovations Ltd.

Responsible Party

Sponsor

•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

•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