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Ultrasound-Guided vs. Mini-Open Surgery for Carpal Tunnel Syndrome
N/A
Waitlist Available
Led By Matthew Miller, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post ctr procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of two treatments for carpal tunnel syndrome: ultrasound guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (mOCTR).
Who is the study for?
This trial is for adults over 18 with severe or persistent Carpal Tunnel Syndrome (CTS), confirmed by tests showing nerve issues at the wrist. They must speak English and be eligible for military healthcare. People can't join if they've had previous CTS surgery, can't stop blood thinners, have had certain injuries or conditions affecting the arm, or received a recent steroid injection in the carpal tunnel.
What is being tested?
The study compares two surgical techniques for CTS: ultrasound-guided carpal tunnel release (USCTR) using SX-One MicroKnife® versus traditional mini-open release (mOCTR). Participants will be randomly assigned to one of these treatments and followed up for two years to measure recovery and effectiveness.
What are the potential side effects?
Potential side effects may include discomfort at the incision site, swelling, infection risk, temporary nerve irritation or damage, and varying recovery times which could impact return to daily activities including military duties.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post ctr procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post ctr procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in military work status as assessed using single-item self-report assessment
Change in pain medication usage as assessed using single-item self-report assessment
Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS)
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: USCTR ProcedureExperimental Treatment1 Intervention
Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR
Group II: mOCTR ProcedureActive Control1 Intervention
Participants will undergo the traditional mOCTR procedure.
Find a Location
Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,286 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,635 Total Patients Enrolled
Matthew Miller, MDPrincipal InvestigatorWalter Reed National Military Medical Center