CompletedNot Applicable

Clinical Outcomes of USCTR vs. mOCTR

United States41 participantsStarted 2021-03-02

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 transligamentous thenar motor branch or space occupying lesions within the carpal tunnel) * Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT04504019

SponsorWalter Reed National Military Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-09-05

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