Carpal TunnelNCT04504019

Clinical Outcomes of USCTR vs. mOCTR

A study testing USCTR and mOCTR in people with Carpal Tunnel, run by Walter Reed National Military Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Carpal Tunnel
What is being tested?: USCTR and mOCTR
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2021to 6 Aug 2025
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 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults age ≥18 years
DEERS Eligible
Fluent in speaking, reading, and understanding English
Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
Candidate for surgical CTR based on severe and/or refractory symptoms
Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings)
Ultrasound findings consistent with median nerve enlargement in the carpal tunnel

Who cannot join

Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
Unable to understand and provide written informed consent
Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as transligamentous thenar motor branch or space occupying lesions within the carpal tunnel)
Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed National Military Medical Center
Bethesda, Maryland, 20814

Other trials in United States

About this study

Official title: Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single < 1 cm wrist or palmar incision (USCTR or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial.

Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional mOCTR. All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure, with the primary focus being on outcomes up to 1 year.

Read the detailed description

Clinical outcomes of up to 83 participants (updated target sample size) treated with USCTR vs. traditional mOCTR will be investigated.

Conditions: Carpal Tunnel
Being tested: USCTR, mOCTR
Keywords: Median Nerve Neuropathy Treatments, Ultrasound Guided Carpal Tunnel Release (USCTR), Military, Minimally Invasive Carpal Tunnel Release
Medical subject headings: Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

USCTRDevice
Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®, also known as UltraGuideCTR
mOCTRProcedure or surgery
Mini-open CTR via a single 1-3cm palmar incision

Study groups in NCT04504019
Study group	Role	What they receive
USCTR Procedure	Experimental	Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR Receives: Device: USCTR
mOCTR Procedure	Active comparator	Participants will undergo the traditional mOCTR procedure. Receives: Procedure: mOCTR

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in QuickDASH.
QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).
For the primary analysis, change in QuickDASH score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in QuickDASH will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.
Measured: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in BCTQ-SSS.
The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-SSS) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.
For the primary analysis, change in BCTQ-SSS score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in BCTQ-SSS will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.
Measured: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Hand Grip Strength.
Manually tested using a handheld dynamometer.
Between the mOCTR and USCTR groups, will compare hand grip strength across each time point (i.e. baseline - 3 months; baseline - 12 months).
Measured: Change from baseline to 3 months, and 12 months post CTR procedure. Mean grip strength at baseline, 3 months and 12 months were reported.
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Pinch (Tip, Palmar, and Key) Strength.
Manually tested using a pinch gauge.
Between the mOCTR and USCTR groups, will compare pinch (tip, palmar, and key) strength across each time point (i.e. baseline - 3 months; baseline - 12 months).
Measured: Change from baseline to 3 months, and 12 months post CTR procedure. Mean pinch (tip, palmar, and key) strength at baseline, 3 months and 12 months were reported.
Measure the Impact of USCTR vs mOCTR on Participant Perception of Change in Overall Physical Condition
Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)
The Global Rate of Change Scale (GROC) will be captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.
Measured: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. % of participants that reported a GROC score of ≥ 5/7 at 1 month, 1 year, and 2 years were reported.
Change in Military Work Status as Assessed Using Single-item Self-report Assessment
Participants will complete a questionnaire to depict when normal work or daily activities commenced.
The primary focus will be on outcomes up to 1 year.
Measured: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. Status at 1 month, 1 year and 2 years were reported.
Surgical Time During Procedure (Minutes)
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes. Surgical time was defined as the time from initial cut to incision closure.
Measured: Recorded at end of procedure (Baseline)
Change in Self-reported Satisfaction as Assessed Using a Satisfaction Rating Scale
Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.
Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.
Will compare participant satisfaction across arms in terms of symptom improvement, incision appearance, and recovery, with the primary focus being on outcomes up to 1 year.
Measured: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. % of participants that reported a score of ≥ 5/7 at 1 month, 1 year and 2 years were reported.
Change in Self-reported Pain as Assessed Using the 11-item Numeric Pain Rating Scale (NPRS) Participant Pain Levels Over 1 Month Following the CTR Procedure.
The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Measured: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure. Change from baseline to 1 month was reported.
Change in Pain Medication Usage as Assessed Using Single-item Self-report Assessment
Participant self-reported pain medication usage. Pain medication use frequency was self-reported on a scale from 0-5. The following frequency of use options are as follows: 0 = No use, 1 = Less than once a week, 2 = Once a week, 3 = Several times a week, 4 = Daily, 5 = Multiple times per day.
Participant self-reported pain medication usage (e.g., cumulative dosage, drug category, duration of use, etc.) will be captured at nine occasions of assessment: 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.
Measured: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. Mean opioid use frequency at baseline and 1 week were reported due to highest clinical relevance.
Incision Length in mm
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in mm
Measured: Recorded at end of procedure (Baseline)
Change in Self-reported Pain as Assessed Using the 11-item Numeric Pain Rating Scale (NPRS)
Using the 11-item Numeric Pain Rating Scale (NPRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.
The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Measured: Pre-procedure (Baseline) and Immediately post-procedure. Mean immediate post-procedure pain scores were reported.
Change in Self-reported Pain as Assessed Using the Modified 2-item CTS Palmar Pain Scale (4 Items) Over 1 Month Following CTR Procedure
The Modified 2-item CTS Palmar Pain Scale allows participants to report on their palmar (including pillar pain) and incisional pain and their impact on function separately, with higher scores indicating more pain and functional interference. The amount of palmar and incisional pain was assessed on a scale from 0 (No pain) to 6 (Very severe) and the impact of palmar and incisional pain on function was assessed on a scale from 0 (Not at all) to 5 (Extremely).
Measured: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure. Mean incisional pain score was reported at 4 weeks and mean incisional pain impact on function score was reported at 3 weeks due to highest clinical relevance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20216 Aug 2025

First posted7 Aug 2020
Study start2 Mar 2021
Primary completion5 Sep 2023
Study completion6 Aug 2025

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.
Other trials for Carpal TunnelStudies 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: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04504019
Sponsor's protocol ID: WRNMMC-2020-0278
Status last verified: Sep 2025
First submitted: 22 Jun 2020
Last updated: 3 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance
ClinicalTrials.gov ID: NCT04504019
Acronym / sponsor ID: WRNMMC-2020-0278
Conditions: Carpal Tunnel
Keywords: Median Nerve Neuropathy Treatments, Ultrasound Guided Carpal Tunnel Release (USCTR), Military, Minimally Invasive Carpal Tunnel Release
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Walter Reed National Military Medical CenterUS federal agency
Collaborators: Uniformed Services University of the Health Sciences
Study start: 2 Mar 2021 (actual)
Primary completion: 5 Sep 2023 (actual)
Study completion: 6 Aug 2025 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 3 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Clinical outcomes of up to 83 participants (updated target sample size) treated with USCTR vs. traditional mOCTR will be investigated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
USCTR Procedure	Experimental	Device: USCTRParticipants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR
mOCTR Procedure	Active comparator	Procedure: mOCTRParticipants will undergo the traditional mOCTR procedure.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adults age ≥18 years
DEERS Eligible
Fluent in speaking, reading, and understanding English
Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
Candidate for surgical CTR based on severe and/or refractory symptoms

Key exclusion criteria (8 listed)

Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox

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
USCTRUltrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®, also known as UltraGuideCTR	Device	USCTR Procedure
mOCTRMini-open CTR via a single 1-3cm palmar incision	Procedure or surgery	mOCTR Procedure

Primary outcome

Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in QuickDASH.
Time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.
QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability). For the primary analysis, change in QuickDASH score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in QuickDASH will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in BCTQ-SSS.
Time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.
The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-SSS) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score. For the primary analysis, change in BCTQ-SSS score will be tracked across the first five occasions of assessment (i.e. baseline - 1 month) and the patient-level average trend will be compared between randomized groups. As a secondary analysis, change in BCTQ-SSS will be tracked over the full duration of follow-up, with the primary focus being on outcomes up to 1 year.
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Hand Grip Strength.
Time frame: Change from baseline to 3 months, and 12 months post CTR procedure. Mean grip strength at baseline, 3 months and 12 months were reported.
Manually tested using a handheld dynamometer. Between the mOCTR and USCTR groups, will compare hand grip strength across each time point (i.e. baseline - 3 months; baseline - 12 months).
Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Pinch (Tip, Palmar, and Key) Strength.
Time frame: Change from baseline to 3 months, and 12 months post CTR procedure. Mean pinch (tip, palmar, and key) strength at baseline, 3 months and 12 months were reported.
Manually tested using a pinch gauge. Between the mOCTR and USCTR groups, will compare pinch (tip, palmar, and key) strength across each time point (i.e. baseline - 3 months; baseline - 12 months).
Measure the Impact of USCTR vs mOCTR on Participant Perception of Change in Overall Physical Condition
Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. % of participants that reported a GROC score of ≥ 5/7 at 1 month, 1 year, and 2 years were reported.
Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same) The Global Rate of Change Scale (GROC) will be captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.
Change in Military Work Status as Assessed Using Single-item Self-report Assessment
Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. Status at 1 month, 1 year and 2 years were reported.
Participants will complete a questionnaire to depict when normal work or daily activities commenced. The primary focus will be on outcomes up to 1 year.
Surgical Time During Procedure (Minutes)
Time frame: Recorded at end of procedure (Baseline)
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes. Surgical time was defined as the time from initial cut to incision closure.
Change in Self-reported Satisfaction as Assessed Using a Satisfaction Rating Scale
Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. % of participants that reported a score of ≥ 5/7 at 1 month, 1 year and 2 years were reported.
Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied. Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score. Will compare participant satisfaction across arms in terms of symptom improvement, incision appearance, and recovery, with the primary focus being on outcomes up to 1 year.
Change in Self-reported Pain as Assessed Using the 11-item Numeric Pain Rating Scale (NPRS) Participant Pain Levels Over 1 Month Following the CTR Procedure.
Time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure. Change from baseline to 1 month was reported.
The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Change in Pain Medication Usage as Assessed Using Single-item Self-report Assessment
Time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure. Mean opioid use frequency at baseline and 1 week were reported due to highest clinical relevance.
Participant self-reported pain medication usage. Pain medication use frequency was self-reported on a scale from 0-5. The following frequency of use options are as follows: 0 = No use, 1 = Less than once a week, 2 = Once a week, 3 = Several times a week, 4 = Daily, 5 = Multiple times per day. Participant self-reported pain medication usage (e.g., cumulative dosage, drug category, duration of use, etc.) will be captured at nine occasions of assessment: 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-CTR. The primary focus will be on outcomes up to 1 year.
Incision Length in mm
Time frame: Recorded at end of procedure (Baseline)
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in mm
Change in Self-reported Pain as Assessed Using the 11-item Numeric Pain Rating Scale (NPRS)
Time frame: Pre-procedure (Baseline) and Immediately post-procedure. Mean immediate post-procedure pain scores were reported.
Using the 11-item Numeric Pain Rating Scale (NPRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups. The 11-item NPRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Change in Self-reported Pain as Assessed Using the Modified 2-item CTS Palmar Pain Scale (4 Items) Over 1 Month Following CTR Procedure
Time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure. Mean incisional pain score was reported at 4 weeks and mean incisional pain impact on function score was reported at 3 weeks due to highest clinical relevance.
The Modified 2-item CTS Palmar Pain Scale allows participants to report on their palmar (including pillar pain) and incisional pain and their impact on function separately, with higher scores indicating more pain and functional interference. The amount of palmar and incisional pain was assessed on a scale from 0 (No pain) to 6 (Very severe) and the impact of palmar and incisional pain on function was assessed on a scale from 0 (Not at all) to 5 (Extremely).

Results and safety

Results posted to the registry on 3 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
USCTR Procedure	21	21
mOCTR Procedure	20	20

Primary outcome: Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in QuickDASH.

Time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.. Mean (Standard Deviation). Unit: units on a scale from 0-100

Measure	USCTR Procedure n = 21	mOCTR Procedure n = 20
Mean Change from Baseline to 1 Month Post-Procedure	-8.2 (17.1)	-8.4 (13.6)
Mean Change from Baseline to 1 Year Post-Procedure	-19.4 (23.1)	-26.6 (16.6)
Mean Change from Baseline to 2 Years Post-Procedure	-16.3 (22.9)	-26.5 (20.1)

USCTR Procedure vs mOCTR Procedure: p = 0.510, Generalized Additive Model
USCTR Procedure vs mOCTR Procedure: p = 0.652, Generalized Additive Model

Primary outcome: Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in BCTQ-SSS.

Measure	USCTR Procedure n = 21	mOCTR Procedure n = 20
Mean Change from Baseline to 1 Month Post-Procedure	-0.9 (0.8)	-1.2 (0.7)
Mean Change from Baseline to 1 Year Post-Procedure	-1.3 (1.0)	-1.5 (0.9)
Mean Change from Baseline to 2 Years Post-Procedure	-1.1 (0.8)	-1.6 (0.9)

USCTR Procedure vs mOCTR Procedure: p = 0.362, Generalized Additive Model
USCTR Procedure vs mOCTR Procedure: p = 0.214, Generalized Additive Model

Primary outcome: Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Hand Grip Strength.

Time frame: Change from baseline to 3 months, and 12 months post CTR procedure. Mean grip strength at baseline, 3 months and 12 months were reported.. Mean (Standard Deviation). Unit: kg

Measure	USCTR Procedure n = 21	mOCTR Procedure n = 20
Mean Grip Strength at Baseline	28.6 (14.0)	24.7 (12.9)
Mean Grip Strength at 3 Months Post-Procedure	27.3 (13.2)	24.3 (10.5)
Mean Grip Strength at 12 Months Post-Procedure	30.3 (14.4)	31.7 (10.4)

USCTR Procedure vs mOCTR Procedure: p = 0.7442, Generalized Additive Models
USCTR Procedure vs mOCTR Procedure: p = 0.1797, Generalized Additive Model

Population analysed: Measurements only available for 19 mOCTR participants at 3-month follow-up. Measurements only available for 20 CTR-US and 17 mOCTR participants at 12-month follow-up.

Primary outcome: Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in Pinch (Tip, Palmar, and Key) Strength.

Time frame: Change from baseline to 3 months, and 12 months post CTR procedure. Mean pinch (tip, palmar, and key) strength at baseline, 3 months and 12 months were reported.. Mean (Standard Deviation). Unit: kg

Measure	USCTR Procedure n = 21	mOCTR Procedure n = 20
Mean Tip Pinch Strength at Baseline	5.5 (1.5)	4.8 (1.9)
Mean Tip Pinch Strength at 3 Months Post-Procedure	6.1 (2.1)	4.9 (1.3)
Mean Tip Pinch Strength at 12 Months Post-Procedure	6.2 (1.9)	5.9 (1.3)
Mean Palmar Pinch Strength at Baseline	6.6 (1.7)	5.8 (2.0)
Mean Palmar Pinch Strength at 3 Months Post-Procedure	7.0 (2.2)	6.1 (1.5)
Mean Palmar Pinch Strength at 12 Months Post-Procedure	7.2 (2.3)	6.7 (1.5)
Mean Key Pinch Strength at Baseline	8.0 (2.2)	7.5 (2.1)
Mean Key Pinch Strength at 3 Months Post-Procedure	8.2 (2.3)	7.4 (1.6)

USCTR Procedure vs mOCTR Procedure: p = 0.4271, Generalized Additive Model
USCTR Procedure vs mOCTR Procedure: p = 0.9067, Generalized Additive Model
USCTR Procedure vs mOCTR Procedure: p = 0.7999, Generalized Additive Model

Population analysed: Measurements only available for 19 mOCTR participants at 3-month follow-up. Measurements only available for 20 CTR-US and 17 mOCTR participants at 12-month follow-up.

Adverse events

Time frame: Adverse events were assessed over 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
USCTR Procedure	4 of 21 (19%)	4 of 21 (19%)	0 of 21
mOCTR Procedure	0 of 20 (0%)	3 of 20 (15%)	0 of 20

Limitations and caveats (from the sponsor): The participants and the investigators were not blinded. The target sample size was not met due to recruitment challenges (i.e., COVID-19 pandemic) within the funding period that prompted early end to enrollment. 5 mOCTR procedures were performed in the OR versus clinic procedure room (staffing limitations). The CTR-US procedures were the first procedures performed by the PM\&R physicians. All CTR-US patients were treated with a specific US-guided technique that may not be generalizable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Matthew Miller, MD principal investigator

Walter Reed National Military Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing USCTR and mOCTR in people with Carpal Tunnel, run by Walter Reed National Military Medical Center at 1 site 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 7 inclusion and 8 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 Nov 2026). 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?

Measure the Effect of USCTR vs mOCTR on the Longitudinal Change in QuickDASH. (time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure were assessed. Change from baseline to 1 month, 1 year and 2 years were reported.). The study lists 13 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 NCT04504019.

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 3 Nov 2026.