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Ultrasound vs Traditional Surgery for Carpal Tunnel Syndrome (TUTOR Trial)
TUTOR Trial Summary
This trial will compare two different types of carpal tunnel surgery to see which is more effective and has fewer complications.
TUTOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTUTOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TUTOR Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with carpal tunnel syndrome in one or both hands.I am on dialysis for chronic kidney failure.I've tried treatments like exercise changes or injections without success.I have a systemic inflammatory disease like rheumatoid arthritis or lupus.I don't have carpal tunnel symptoms in my other hand that stop me from daily work.My hand or wrist needs more treatment than just carpal tunnel surgery.My diabetes has not been stable on my current medication for the last 3 months.I had surgery for carpal tunnel in my other hand within the last 3 months or still have symptoms that affect my daily life.I have tried and not benefited from non-surgical treatments like braces or injections for my hand.I don't have carpal tunnel symptoms in my other hand that stop me from daily work.I have a working mobile phone and email for follow-ups.I have been diagnosed with carpal tunnel syndrome in one or both hands.I have a significant injury or deformity in my arm from shoulder to hand.I have a serious nerve condition in my arm from shoulder to hand.I haven't had a corticosteroid injection in my wrist or hand in the last 6 weeks.I agree to fill out questionnaires for a year.I am scheduled for surgery on the opposite wrist or hand.I am 18 years old or older.I have a significant inflammation in my arm, from shoulder to hand.I have had surgery for carpal tunnel syndrome on the hand in question.I have severe arthritis in my arm from shoulder to hand.I had surgery on my hand or wrist but have fully recovered, except for trigger finger surgery.I have a serious blood vessel condition in my arm on the same side as my target treatment area.My thyroid condition is not under control.I have been diagnosed with amyloidosis.I am 18 years old or older.You have severe hand pain with a CTS-6 score higher than 12.I have been diagnosed with carpal tunnel syndrome without a known cause.My other hand does not have severe carpal tunnel syndrome.Your contralateral hand has a CTS-6 score of less than 12.
- Group 1: Carpal Tunnel Release with Ultrasound Guidance (CTR-US)
- Group 2: Mini Open Carpel Tunnel Release (mOCTR)
- 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
In how many distinct locations is this experiment being carried out?
"University of Mississippi in Jackson, Tri-State Orthopaedics in Evansville and Sierra Orthopedic Institute based out of Sonora are among the dozen trial sites currently recruiting patients for this medical study."
What are the primary aims of this clinical investigation?
"Sonex Health, Inc., the trial sponsor, has declared that this study's primary objective will be monitored over a 3 month period and is centered on the time it takes for participants to return to their regular routine. Additionally, secondary outcomes such as BCTQ-FSS Change (the mean difference in between-group change scores), BCTQ-SSS Change (the mean difference in between group SSS change score) and Numeric Pain Scale Change (mean differences in pain scale changes scored from 0 to 10 with zero indicating no pain and ten being worst possible pain) shall be tracked."
Are there openings in this clinical trial for participants right now?
"As of now, this clinical trial is enrolling patients. The study was originally published on July 26th 2022 and its information has been edited as recently as November 15th 2022."
How many subjects are participating in the research project?
"That is correct. According to the information available on clinicaltrials.gov, this research study began enrolling participants in July of 2022 and is still actively recruiting as of November 15th 2022. 120 patients must be recruited from 12 different locations for it to move forward with its intended goals."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
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