CTR using Ultrasound Guidance: Two-Year RCT Outcomes within MHS- SOMOS 2024

m smith, x yuan, j smith, j banks deal jr, g nanos, s tintle, d reece, m miller

Abstract awarded the Jamie Dianne Bulken-Hoover Memorial- Best Hand Paper at The Society of Military Orthopedic Surgeons Annual Meeting in Nashville, TN- December 2024

Carpal tunnel release (CTR) using a mini-open (mOCTR) or endoscopic approach is the current standard of care (SOC) in the Military Health System (MHS) for management of refractory carpal tunnel syndrome (CTS), the most common peripheral entrapment neuropathy. CTR techniques have evolved over time to reduce iatrogenic tissue trauma and post-operative pain, promoting quicker recovery and improved outcomes. CTR using Ultrasound Guidance (CTR-US) is a promising treatment option under study for military beneficiaries with CTS in a trial comparing outcomes of CTR-US and mOCTR.

This single-site pragmatic randomized controlled feasibility trial at Walter Reed National Military Medical Center (WRNMMC) was approved by the Institutional Review Board (WRNMMC-2020-0278). Military beneficiaries (18-89 years) with clinical, electrodiagnostic, and sonographic findings consistent with CTS were enrolled. Exclusion criteria included prior wrist surgery, median nerve trauma, or sonographic findings precluding safe and effective CTR-US.

Participants were randomized to receive either CTR-US by board-certified Physical Medicine and Rehabilitation physicians with advanced training in ultrasound-guided procedures in a clinic procedure room with local anesthesia, or mOCTR by board-certified Orthopedic Hand Surgeons in a clinic procedure room with local anesthesia or operating room (OR) with moderate sedation. CTR-US was performed under continuous ultrasound guidance with a device featuring inflatable balloons to create space within the carpal tunnel and a retractable blade that releases the transverse carpal ligament in a retrograde manner.

Demographics and patient-reported outcome measures (PROMs) were collected at baseline. Follow-up PROMs were collected at 1, 2, 3, 4, 6 weeks, 3, 6, 12, and 24 months post-procedure. The primary outcome was the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 1 month. Additional outcomes included Boston Carpal Tunnel Questionnaire – Symptom Severity Scale (BCTQ-SS), Numerical Pain Rating Scale (NPRS), Global Assessment of Satisfaction, Global Rating of Change (GROC), modified 2-item CTS Palmar Pain Scale; grip and pinch strength (3 and 12 months); procedure time and incision length; and adverse events. Descriptive analyses reported central tendencies in terms of location (e.g., mean) and scale (e.g., standard deviation) for all study variables. Inferential analyses included two-sample Welch’s T-tests (α = 0.01) for procedural data and complete-case, intention-to-treat, generalized additive models incorporating multi-level structures through patient-level random effects for all other outcomes. No confidence interval (α = 0.05) overlaps on generalized additive models indicated statistical significance.

CTS is the most common peripheral entrapment neuropathy, impacting the health of military beneficiaries. CTS treatment barriers within the MHS include limited access to subspecialty care, lack of resources, and OR procedural costs. Preliminary data from this trial suggest that CTR-US can be performed within a clinic environment by non-operative physicians with advanced training, resulting in decreased post-procedural incisional pain and non-inferior outcomes compared to mOCTR approach out to 2 years. Outcomes of this WRNMMC trial can facilitate expansion of available CTS management options within the MHS, improving access to care and operational readiness.