Clinical trial NCT04504019: Clinical Outcomes of USCTR vs. mOCTR
Official title: Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carpal Tunnel
Keywords: Median Nerve Neuropathy Treatments
Ultrasound Guided Carpal Tunnel Release (USCTR)
Military
Minimally Invasive Carpal Tunnel Release
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2020-08-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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: 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: 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: 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: 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
measure: Change in military work status as assessed using single-item self-report assessment
timeFrame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
measure: Surgical time during procedure (minutes)
timeFrame: At time of procedure, measured as day 0
measure: Change in self-reported satisfaction as assessed using a satisfaction rating scale
timeFrame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
measure: 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.
timeFrame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
measure: Change in pain medication usage as assessed using single-item self-report assessment
timeFrame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
measure: Incision length in cm
timeFrame: At time of procedure, measured as day 0
measure: Change in self-reported pain as assessed using the 11-item Numeric Pain Rating Scale (NPRS)
timeFrame: At time of procedure, measured as day 0
measure: Change in self-reported pain as assessed using the modified 2-item CTS Palmar Pain Scale (4 items) over 1 month following CTR procedure
timeFrame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Matthew Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: