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Procedure

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 below
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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.
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I am 18 years old or older.

TUTOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month follow-up for reporting.

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 more
Secondary 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

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

Media Library

CTR-US (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05405218 — N/A
Carpal Tunnel Syndrome Research Study Groups: Carpal Tunnel Release with Ultrasound Guidance (CTR-US), Mini Open Carpel Tunnel Release (mOCTR)
Carpal Tunnel Syndrome Clinical Trial 2023: CTR-US Highlights & Side Effects. Trial Name: NCT05405218 — N/A
CTR-US (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405218 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
Indiana
How old are they?
18 - 65
What site did they apply to?
University of Mississippi
Indiana Hand to Shoulder
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~45 spots leftby Mar 2025