Carpal Tunnel SyndromeTUTORNCT05405218
Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
A study testing CTR with Ultrasound Guidance using the UltraGuideCTR device and mOCTR in people with Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 12 sites in United States.
Trial summary
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, CTS, Carpal Tunnel
- What is being tested?
- CTR with Ultrasound Guidance using the UltraGuideCTR device and mOCTR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Aug 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Clinical diagnosis of unilateral or bilateral idiopathic CTS
- CTS-6 score >12 in target hand
- Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively
- Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound
- Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
- Subject agrees to complete follow-up questionnaires over a 12-month period
- Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires
Who cannot join
- Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered
- History of prior surgical CTR procedure in the target hand
- History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
- Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)
- Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side
Show all 20Show fewer
- Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side
- Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side
- Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side
- Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side
- Planned surgical or interventional procedure on the contralateral wrist or hand
- Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
- Amyloidosis
- Chronic renal insufficiency requiring dialysis
- Diabetes not controlled by a stable dose of medication over the past three months
- Uncontrolled thyroid disease
- Pregnant or planning pregnancy in the next 12 months
- Workers compensation subjects
- Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
- Subject has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
ATX Orthopedics
Austin, Texas, 78756
Massachusetts General Hospital
Boston, Massachusetts, 02114
Tri-State Orthopaedics
Evansville, Indiana, 47715
Midwest Orthopedic Group
Farmington, Missouri, 63640
Orthopedic Associates
Fort Walton Beach, Florida, 32547
Indiana Hand to Shoulder
Indianapolis, Indiana, 46260
University of Mississippi
Jackson, Mississippi, 39216
Sano Orthopedics
Lee's Summit, Missouri, 64064
Twin Cities Orthopedics
Plymouth, Minnesota, 55441
Sierra Orthopedic Institute
Sonora, California, 95370
Washington University
St Louis, Missouri, 63129
Kansas Orthopaedic Center
Wichita, Kansas, 67205
About this study
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
- Conditions
- Carpal Tunnel Syndrome, CTS, Carpal Tunnel
- Being tested
- CTR with Ultrasound Guidance using the UltraGuideCTR device, mOCTR
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTR with Ultrasound Guidance using the UltraGuideCTR deviceDevice
Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
mOCTRProcedure or surgery
Mini Open Carpal Tunnel Release
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device | Experimental | Not described Receives: Device: CTR with Ultrasound Guidance using the UltraGuideCTR device |
| Mini Open Carpal Tunnel Release (mOCTR) | Active comparator | Not described Receives: Procedure: mOCTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Measured: 3 Month Follow-Up
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Measured: 3 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start8 Aug 2022
- Primary completion6 Apr 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonex Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Eberlin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405218
- Sponsor's protocol ID
- 90079-TP
- Acronym
- TUTOR
- Status last verified
- May 2025
- First submitted
- 31 May 2022
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eberlin KR, Amis BP, Berkbigler TP, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Perry PE, Walker ME, Watt JF. Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.
PubMed 37254502Eberlin KR, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Walker ME, Watt JF. Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR). Medicine (Baltimore). 2022 Oct 14;101(41):e30775. doi: 10.1097/MD.0000000000030775.
PubMed 36254038
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
- ClinicalTrials.gov ID
- NCT05405218
- Acronym / sponsor ID
- TUTOR / 90079-TP
- Conditions
- Carpal Tunnel Syndrome, CTS, Carpal Tunnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Sonex Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device | Experimental | Device: CTR with Ultrasound Guidance using the UltraGuideCTR device |
| Mini Open Carpal Tunnel Release (mOCTR) | Active comparator | Procedure: mOCTR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age
- Clinical diagnosis of unilateral or bilateral idiopathic CTS
- CTS-6 score >12 in target hand
- Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively
- Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound
Key exclusion criteria (20 listed)
- Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered
- History of prior surgical CTR procedure in the target hand
- History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
- Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTR with Ultrasound Guidance using the UltraGuideCTR deviceCarpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device | Device | Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device |
| mOCTRMini Open Carpal Tunnel Release | Procedure or surgery | Mini Open Carpal Tunnel Release (mOCTR) |
Primary outcome
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
Time frame: 3 Month Follow-Up
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
Time frame: 3 Month Follow-Up
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37254502Eberlin KR, Amis BP, Berkbigler TP, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Perry PE, Walker ME, Watt JF. Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.
- Derived from this study: PubMed 36254038Eberlin KR, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Walker ME, Watt JF. Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR). Medicine (Baltimore). 2022 Oct 14;101(41):e30775. doi: 10.1097/MD.0000000000030775.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Eberlin, MD principal investigator
Massachusetts General Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTR with Ultrasound Guidance using the UltraGuideCTR device and mOCTR in people with Carpal Tunnel Syndrome and CTS, run by Sonex Health, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change (time frame: 3 Month Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405218, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.