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USCTR 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

Study 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.Check my eligibility
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.See study design
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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post ctr procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

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
138 Previous Clinical Trials
33,497 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
90,470 Total Patients Enrolled
Matthew Miller, MDPrincipal InvestigatorWalter Reed National Military Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for participants in this clinical experiment?

"Affirmative. The clinicaltrial.gov portal indicates that this research endeavour, which was first published on the 11th of December 2020, is actively enrolling participants. Presently, 510 subjects are needed from one medical site."

Answered by AI

May I be considered as a participant in this experiment?

"The enrolment criteria for this medical trial requires participants to have carpal tunnel syndrome and be between 18 - 89 years of age. A total of 510 patients are required across all sites involved in the study."

Answered by AI

Can adults aged 25 and above participate in this experiment?

"To qualify for the trial, applicants must be between 18 and 89 years old. There are also two trials available specifically to those under 18, as well as 43 studies targeting patients aged 65 or above."

Answered by AI

Has the recruitment period for this investigation expired?

"Affirmative. Clinicaltrials.gov lists this medical trial, which was first posted on December 11th 2020, as actively accepting participants. The research team needs to recruit 510 individuals from 1 site in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Virginia
How old are they?
18 - 65
What site did they apply to?
Walter Reed National Military Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Clinical Outcomes of USCTR vs. mOCTR
2021. "Clinical Outcomes of USCTR vs. mOCTR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504019.
All > Carpal Tunnel
~10 spots leftby May 2025
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