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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810326
• Other study ID #: VY-CTS1-01
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: Yuinvent Innovations Ltd.
• Contact: Oleg Dulcart, PHd
• Phone: +972-(0)524-262544
• Email: olegd[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• CTR device (tradename named Xtend)
Non invasive active splint

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Yuinvent Innovations Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain score	Reduction in NRS reported pain score	10 weeks