1. 2024;27;303-307Percutaneous Coracohumeral Release for Patients with Adhesive Capsulitis: Two-Year Results from a Randomized Control Crossover Study
   Randomized Controlled Trial
   Ugur Yener, MD, Tahereh Naeimi, MD, Alan D. Kaye, MD, PhD, Konrad Izumi Gruson, MD, Sandeep Yerra, MD, Jonathan Alerte, MD, David Gonzalez, MD, Pramod Badu Voleti, MD, Eloy Tabeayo Alvarez, MD, and Sayed Emal Wahezi, MD.

BACKGROUND: Adhesive capsulitis (AC) causes a variety of symptoms, including but not limited to pain, stiffness, and a gradual restriction of active and passive range of motion (ROM). The coracohumeral ligament (CHL) plays an important role in this disease process, and percutaneous CHL release (PCHLR) has demonstrated efficacy in treating manifestations of this disorder that are refractory to pain medication, physical therapy, and local injections. Our previous study demonstrated one-year efficacy and durability, and this study examines 2-year data from our original randomized control crossover cohort.

OBJECTIVE: To highlight the importance of extended follow-ups evaluating PCHLR’s efficacy in AC management.

STUDY DESIGN: A prospective, randomized, controlled, cross-over trial.

SETTING: An academic medical center.

METHODS: Patients with AC refractory to oral medication, physiotherapy, and at least one local injection were included in our original study. In all, there were initially 40 patients (46 shoulders), including 6 patients who underwent bilateral PCHLR using the Tenex® system. In this prospective study, 2 groups, the experiment group (scheduled to receive PCHLR) and the control group (scheduled to receive a local anesthetic in the coracohumeral ligament [LACHL]) were determined through 2-to-1 block randomization. Of these 46 shoulders initially treated, 39 remained in the study at one year. Twenty-six of the 39 shoulders were assigned to the PCHLR group whereas 13 were assigned to the LACHL group. Nine out of 13 shoulders in the LACHL group crossed over to the PCHLR group. Ultimately, 31 shoulders remained in the PCHLR group for 2-year analysis. The effectiveness of these interventions was assessed using a variety of parameters. Pain scores, ROM, and the Oxford Shoulder Score (OSS) were evaluated before the procedure and at one-year and 2-year follow-up visits.

RESULTS: In this 2-year follow-up study, a total of 31 shoulders were sampled, comprising 22 women and 5 men, with 4 patients undergoing bilateral procedures. The mean age of the patients was 65 years (± 11.48). Patients’ mean body mass index (BMI) was 36.33 (± 6.55), and the mean CHL thickness was 38.5 (± 3.45). Osteoarthritis was present in 11 cases. The mean follow-up period for the study was 29.7 months (± 6.39). The baseline mean external rotation was 30° (± 8), which increased to 62° (± 18) at one year and 53° (± 18) at 2 years. The baseline mean abduction was 60° (± 16), which improved to 77° (± 21) at one year and 68° (± 20) at 2 years. The median NRS decreased from 8 (IQR: 8, 9) at baseline to 3 (IQR: 2, 7) at one year and 5 (IQR: 2, 7) at 2 years. The baseline median OSS was 7 (IQR: 3, 10), which increased to 32 at one year and 22 (IQR: 15, 35) at 2 years.

LIMITATIONS: The present investigation has a limited sample size of patients who have ROM impairment caused by CHL thickening.

CONCLUSIONS: While the algorithm for AC care has seen little change for several decades, the authors suggest that PCHLR is a safe, durable, and effective option for cases of AC that are refractory to traditional management.