Clinical Outcomes of USCTR vs. mOCTR

NCT04504019 | Completed DMC FDA Device

• 1 other identifier: WRNMMC-2020-0278
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel

Keywords

Median Nerve Neuropathy Treatments; Ultrasound Guided Carpal Tunnel Release (USCTR); Military; Minimally Invasive Carpal Tunnel Release

Outcome Measures

Primary Outcomes (13)

• 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.

  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

• 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.

  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

• 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).

  Change from baseline to 3 months, and 12 months post CTR procedure

• 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).

  Change from baseline to 3 months, and 12 months post CTR procedure

• 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 nine occasions of assessment: baseline and 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 from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

• 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.

  Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

• 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

  At time of procedure, measured as day 0

• 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.

  Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

• 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).

  Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure

• Change in pain medication usage as assessed using single-item self-report assessment

  Participant self-reported pain medication usage. Participant will respond with responses ranging from "less than once a week', "once a week", "several times a week", "daily", "multiple times per day", "or did not use". "Did not use" will represent the minimum value, and "multiple times per day" will represent the maximum value. 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.

  Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure

• Incision length in cm

  On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm

  At time of procedure, measured as day 0

• 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).

  At time of procedure, measured as day 0

• 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 (4 items on palmar and incision pain) inquires about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms

  Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure

Study Arms (2)

USCTR Procedure

EXPERIMENTAL

Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR

Device: USCTR

mOCTR Procedure

ACTIVE COMPARATOR

Participants will undergo the traditional mOCTR procedure.

Procedure: mOCTR

Interventions

USCTR DEVICE

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

USCTR Procedure

mOCTR PROCEDURE

Mini-open CTR via a single 1-3cm palmar incision

mOCTR Procedure

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Matthew Miller, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: August 7, 2020
• Study Start: March 2, 2021
• Primary Completion: September 5, 2023
• Study Completion: August 6, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)