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Ultrasound vs Traditional Surgery for Carpal Tunnel Syndrome (TUTOR Trial)
N/A
Waitlist Available
Led By Kyle Eberlin, 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
Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
Clinical diagnosis of unilateral or bilateral idiopathic CTS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month follow-up
Awards & highlights
TUTOR Trial Summary
This trial will compare two different types of carpal tunnel surgery to see which is more effective and has fewer complications.
Who is the study for?
Adults over 18 with Carpal Tunnel Syndrome (CTS) who've tried non-surgical treatments without success can join. They must have a CTS-6 score >12, no prior wrist surgeries except for trigger finger, and no significant other hand issues or systemic diseases like rheumatoid arthritis. Pregnant women or those planning pregnancy within a year are excluded.Check my eligibility
What is being tested?
The trial compares two types of carpal tunnel surgery: one using ultrasound guidance (CTR-US) and the other a mini-open approach (mOCTR). It aims to determine which is safer and more effective for treating symptoms of CTS.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgical site, swelling, infection risk, nerve damage risks associated with any hand surgery, and possible incomplete relief of carpal tunnel symptoms.
TUTOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried and not benefited from non-surgical treatments like braces or injections for my hand.
Select...
I have been diagnosed with carpal tunnel syndrome in one or both hands.
Select...
I am 18 years old or older.
TUTOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-SSS) Change
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
Device or Procedure related Adverse Events
+4 moreSecondary outcome measures
BCTQ-FSS Change
BCTQ-SSS Change
EQ-5D-5L Change
TUTOR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Carpal Tunnel Release with Ultrasound Guidance (CTR-US)Experimental Treatment1 Intervention
Group II: Mini Open Carpel Tunnel Release (mOCTR)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTR-US
2022
N/A
~130
Find a Location
Who is running the clinical trial?
Sonex Health, Inc.Lead Sponsor
3 Previous Clinical Trials
2,560 Total Patients Enrolled
3 Trials studying Carpal Tunnel Syndrome
2,560 Patients Enrolled for Carpal Tunnel Syndrome
Kyle Eberlin, MDPrincipal InvestigatorMassachusetts General Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Carpal Tunnel Release with Ultrasound Guidance (CTR-US)
- Group 2: Mini Open Carpel Tunnel Release (mOCTR)
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.
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