Mini-incision carpal tunnel release using the ProMIS kit was associated with faster early pain relief and functional recovery compared with open carpal tunnel release in a randomized controlled trial, with some differences between groups persisting through 2 months, although long-term outcomes remain uncertain.
In the single-center trial, 90 patients with idiopathic carpal tunnel syndrome were randomly assigned 1:1 to undergo open carpal tunnel release or mini-incision release with the ProMIS kit, reported Saran Malisorn of Naresuan University, Phitsanulok, Thailand, in Advances in Orthopedics. All procedures were performed by a single fellowship-trained hand surgeon, and follow-up was complete through 2 months.
The study’s primary endpoint was change in Boston Carpal Tunnel Questionnaire symptom severity and functional status scores at 2 months, with additional outcomes including pain, functional measures, strength, incision length, operative time, and complications.
At 2 weeks, patients who underwent the mini-incision procedure reported lower pain scores and better functional outcomes. Mean visual analog scale (VAS) pain scores were 1.06 vs 1.75 with open release. Patient-Rated Wrist Evaluation (PRWE) scores were 31 vs 35, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores were 2.37 vs 3.31. Incision length was also shorter with the mini-incision approach (approximately 13 mm vs 22 mm), while grip strength and 2-point discrimination were similar between groups.
At 1 month, the mini-incision group continued to show improved outcomes. Mean VAS pain scores were 0.84 vs 2.04, PRWE scores were 12 vs 16, and QuickDASH scores were 1.22 vs 2.04. Other patient-reported measures, including BCTQ scores, also favored the mini-incision group at this time point.
By 2 months, both groups had improved substantially. However, several differences still favored the mini-incision approach, including lower VAS pain scores, better 2-point discrimination, lower PRWE scores, less pillar pain, and slightly higher grip strength. QuickDASH scores and some other measures were similar between groups, indicating convergence in overall upper-extremity function by this time point.
Operative time was shorter with the mini-incision technique, averaging about 14 minutes compared with 22 minutes for open release.
Baseline demographic characteristics were similar between groups; however, several patient-reported outcome measures—including BCTQ, PRWE, and QuickDASH—were modestly worse in the open-release group before surgery, which may have influenced the magnitude of postoperative differences.
No major complications—including nerve, tendon, or vascular injury, wound infection requiring intervention, or reoperation—were reported in either group during the 2-month follow-up. However, the investigators noted that the modest sample size and short follow-up limit conclusions regarding rare or long-term complications.
Additional limitations include the single-center design, lack of blinding of patients and outcome assessors, baseline imbalances in patient-reported outcomes, and the absence of adjustment for multiple comparisons across numerous secondary endpoints.
The findings suggest that mini-incision carpal tunnel release using the ProMIS kit may offer faster early recovery than open surgery, with some advantages persisting through 2 months, without evidence of increased short-term risk. However, larger, multicenter studies with longer follow-up are needed to determine whether these early benefits translate into meaningful long-term clinical advantages.
No specific funding was reported. The author declared no conflicts of interest.
Source: Advances in Orthopedics
