Clinical Outcomes of USCTR vs. mOCTR

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). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. This study is a multi-site prospective randomized comparative trial.

Participants with CTS will be randomized to a study arm and receive treatment with ultrasound guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (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.

Investigators hypothesize that USCTR using the SX-One MicroKnife® will safely and more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, with less loss of military duty days.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel
• Intervention / Treatment: Device: USCTR; Procedure: mOCTR

• Study Type: Interventional
• Enrollment (Anticipated): 510
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Miller, MD; Phone Number: 301-295-7752; Email: matthew.e.miller78.mil@mail.mil
• Study Contact Backup: Name: Whitley Lucio; Email: whitley.lucio.ctr@usuhs.edu

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Matthew Miller; Email: matthew.e.miller78.mil@mail.mil
      • Principal Investigator: Matthew Miller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 bifid median nerve or space occupying lesions within the carpal tunnel)
• Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: USCTR Procedure; Participants will undergo the USCTR procedure with SX-One MicroKnife®	Device: USCTR; Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®
ACTIVE_COMPARATOR: mOCTR Procedure; Participants will undergo the traditional mOCTR procedure.	Procedure: mOCTR; Mini-open CTR via a single 1-3cm palmar incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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-S.	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-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.	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 pinch and grip strength.	Manually tested using a dynamometer.	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)	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.	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.	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 Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure.	The 11-item NRS 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.	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 Pain Numeric Rating Scale (NRS)	Using the 11-item Pain Numeric Rating Scale (NRS), 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 NRS 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 4-item CTS Palmar Pain Scale over 1 month following CTR procedure	The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries 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

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Matthew Miller, MD, Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2020
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (ACTUAL): August 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Military; Median Nerve Neuropathy Treatments; Ultrasound Guided Carpal Tunnel Release (USCTR); Minimally Invasive Carpal Tunnel Release
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: WRNMMC-2020-0278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No