PURPOSE: The primary objective was to compare the short-term (1-month) and long-term (2-year) outcomes of carpal tunnel release (CTR) using ultrasound guidance (CTR-US) to mini-open CTR (mOCTR) within the United States military population.
METHODS: This single-site, prospective, randomized controlled trial enrolled military beneficiaries with carpal tunnel syndrome (CTS). Participants were randomized to receive either CTR-US in the clinic procedure room setting or mOCTR. Demographics and patient-reported outcome measures (PROs) were collected at baseline and follow-up PROs out to 2-years postprocedure. The primary outcome was the Quick Disabilities of the Arm, Shoulder, and Hand at 1 month. Additional outcomes included the Numeric Pain Rating Scale, Boston Carpal Tunnel Questionnaire - Symptom Severity Scale, Modified 2-item CTS Palmar Pain Scale, and adverse events (2-year window). Complete-case, intention-to-treat, generalized additive models (α = 0.05) were used to compare PROs between groups.
RESULTS: Forty-one participants (58.5% women, 49.5 ± 14.4 years, 41.5% active duty) were randomized and treated (21 CTR-US, 20 mOCTR) with 100% follow-up at 2 years. Both groups demonstrated improved Quick Disabilities of the Arm, Shoulder, and Hand (CTR-US: -8.2 ± 17.1; mOCTR: -8.4 ± 13.6), Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (CTR-US: -0.9 ± 0.8; mOCTR: -1.2 ± 0.7), and Numeric Pain Rating Scale (CTR-US: -1.1 ± 2.7; mOCTR: -1.1 ± 2.1) scores at 1 month with sustained clinically meaningful improvement out to 2 years. The CTR-US group reported less incisional pain and functionally limiting incisional pain during the first 4 and 3 weeks, respectively. One infection was reported in the CTR-US group.
CONCLUSIONS: Both groups had clinically meaningful improvements out to 2 years with respect to pain and CTS symptom reduction, as well as improvement in function. Compared to mOCTR, the CTR-US group reported less incisional pain and functionally limiting incisional pain in the early postprocedural period.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic 1B.
Read the article: PubMed · Publisher (DOI)