CTR-US for Carpal Tunnel Syndrome

Phase-Based Progress Estimates
Vero Orthopaedics, Vero Beach, FLCarpal Tunnel Syndrome+1 MoreUltrasound Guided Carpal Tunnel Release (CTR-US) - Device
All Sexes
What conditions do you have?

Study Summary

This trial studied the effectiveness of using ultrasound to treat Carpal Tunnel Syndrome in an office setting.

Eligible Conditions
  • CT Scan
  • Carpal Tunnel Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 3 Months

3 Months
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Device and/or Procedure Related Adverse Events
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
Global Satisfaction
Michigan Hand Questionnaire (MHQ)
Numeric Pain Scale
Time to Return To Normal Daily Activities (RTA)
Time to Return To Work Among Employed Subjects (RTW)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

140 Total Participants · 1 Treatment Group

Primary Treatment: CTR-US · No Placebo Group · N/A

Experimental Group · 1 Intervention: Ultrasound Guided Carpal Tunnel Release (CTR-US) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Sonex Health, Inc.Lead Sponsor
2 Previous Clinical Trials
531 Total Patients Enrolled
2 Trials studying Carpal Tunnel Syndrome
531 Patients Enrolled for Carpal Tunnel Syndrome
Ashley Pistorio, MDPrincipal InvestigatorUniversity of Nevada, Las Vegas

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older.
You have a smartphone and/or email address where you can receive and respond to follow-up questionnaires.
You have been diagnosed with carpal tunnel syndrome in one or both hands, and the cause is unknown.
You have severe pain and disability in your hand, as measured by a score of more than 12 on the CTS-6 scale.
The median nerve in your hand is too large in the carpal tunnel region, which was measured using an ultrasound.
You have tried different treatments such as exercise, braces, splints or corticosteroid injections before, but they didn't work for you.
You agree to answer questions about your health for 2 years after the study.

Who else is applying?

What state do they live in?
What site did they apply to?
Bluegrass Orthopaedics100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I am looking for relief for my carpal tunnel without having to do surgery. I hope a clinical trial will help. Thank you"
How many prior treatments have patients received?

Frequently Asked Questions

What is the current enrollment of subjects in this research endeavor?

"To move this trial forward, 140 eligible individuals must take part. Bluegrass Orthopaedics (Lexington, Kentucky) and University of Nevada, Las Vegas (Las Vegas, Nevada) are just two sites that can provide recruitment services." - Anonymous Online Contributor

Unverified Answer

How many locations are participating in the implementation of this trial?

"In addition to the existing 3 sites, this medical study is also running out of Bluegrass Orthopaedics in Lexington, Kentucky, University of Nevada Las Vegas in Las Vegas, Nevada and New Braunfels Orthopaedic Surgery and Sports Medicine in Texas." - Anonymous Online Contributor

Unverified Answer

Are enrollment opportunities currently available for this trial?

"Affirmative. The clinical trial is still open according to information on clinicialtrials.gov which was first posted on February 16th 2023 and most recently updated the next day. 140 participants are being sourced from 4 distinct medical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.