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Ultrasound-Guided Surgery for Carpal Tunnel Syndrome (ROBUST Trial)
ROBUST Trial Summary
This trial studied the effectiveness of using ultrasound to treat Carpal Tunnel Syndrome in an office setting.
ROBUST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowROBUST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ROBUST Trial Design
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Who is running the clinical trial?
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- 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 smartphone or email for follow-ups.I agree to fill out questionnaires for 24 months.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 been diagnosed with carpal tunnel syndrome in one or both hands.I am 18 years old or older.I've tried treatments like exercise changes or injections without success.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.Your hand has a CTS-6 score higher than 12.I've had surgery on my wrist or hand, but only minor procedures or for DeQuervain's syndrome, and have fully recovered.I have a smartphone or email for follow-ups.I have had an infection in my hand before.I have been diagnosed with carpal tunnel syndrome in one or both hands.My diabetes is not well-managed with my current medication.I have tried and not improved with treatments like exercise, braces, or injections.I am 18 years old or older.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.I have been diagnosed with carpal tunnel syndrome in one or both hands.I agree to fill out questionnaires for 24 months.
- Group 1: CTR-US
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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