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Procedure
Ultrasound-Guided Surgery for Carpal Tunnel Syndrome (ROBUST Trial)
N/A
Waitlist Available
Led By Ashley Pistorio, MD
Research Sponsored by Sonex Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studied the effectiveness of using ultrasound to treat Carpal Tunnel Syndrome in an office setting.
Who is the study for?
This trial is for adults over 18 with Carpal Tunnel Syndrome (CTS) who've tried non-surgical treatments without success. They must have a CTS-6 score above 12, a median nerve area of at least 10 mm2 in the affected hand, and be able to complete surveys for two years using a smartphone or email. Exclusions include prior surgery on the wrist/hand (except minor procedures), infections, other conditions needing intervention, uncontrolled thyroid disease, pregnancy plans within two years, and inability to consent.
What is being tested?
The ROBUST trial tests an office-based procedure called Ultrasound Guided Carpal Tunnel Release (CTR-US) on patients with symptomatic CTS. It's a single-arm study meaning all participants receive the same treatment without comparison to another group or placebo.
What are the potential side effects?
While specific side effects are not listed here, typical risks of ultrasound-guided carpal tunnel release may include discomfort at the site of treatment, swelling, bruising, infection risk and temporary nerve symptoms like tingling or numbness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Secondary study objectives
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Device and/or Procedure Related Adverse Events
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CTR-USExperimental Treatment1 Intervention
Ultrasound Guided Carpal Tunnel Release (CTR-US)
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Who is running the clinical trial?
Sonex Health, Inc.Lead Sponsor
3 Previous Clinical Trials
2,533 Total Patients Enrolled
3 Trials studying Carpal Tunnel Syndrome
2,533 Patients Enrolled for Carpal Tunnel Syndrome
Ashley Pistorio, MDPrincipal InvestigatorUniversity of Nevada, Las Vegas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had carpal tunnel release surgery on the hand in question.I plan to have surgery on my other hand within 3 months of my first hand surgery.I have a disease that affects my whole body.My thyroid condition is not under control.I have a major injury or deformity in my arm on the same side as my target condition.I have a significant nerve issue in my arm on the same side as my target condition.You have a CTS-6 score higher than 12 in your hand that needs treatment.I have been diagnosed with carpal tunnel syndrome in one or both hands.My hand needs more than just carpal tunnel surgery.I've tried treatments like exercise changes or injections without success.I am 18 years old or older.I had surgery on my other hand within the last 3 months or still have symptoms that affect my daily activities.I have serious blood vessel problems in my arm on the same side as my target treatment area.I have been diagnosed with amyloidosis.I have a smartphone or email for follow-ups.I have a serious inflammation in my arm on the same side as my target treatment area.I have severe arthritis in my arm on the same side as my target condition.I require dialysis for my kidney condition.I have not had a corticosteroid injection in my hand within the last 6 weeks.I've had surgery on my wrist or hand, but only minor procedures or for DeQuervain's syndrome, and have fully recovered.I have had an infection in my hand before.My diabetes is not well-managed with my current medication.Your median nerve in the wrist is larger than 10 square millimeters when measured by ultrasound.I've tried treatments like exercise changes or injections for my condition without success.
Research Study Groups:
This trial has the following groups:- Group 1: CTR-US
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Carpal Tunnel Syndrome Patient Testimony for trial: Trial Name: NCT05675046 — N/A
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