Percutaneous Ultrasound-Guided Coracohumeral Ligament Release for Refractory Adhesive Capsulitis: A Prospective, Randomized, Controlled, Crossover Trial Demonstrating One-Year Efficacy

Background: Adhesive capsulitis (AC) is a painful and disabling condition with restricted range of motion (ROM) that affects 2% to 3% of the population and up to 20% of patients with diabetes. AC can be idiopathic, iatrogenic, or secondary to shoulder injuries. Some associated conditions include diabetes mellitus, thyroid disorders, dyslipidemia, stroke, prolonged immobilization, and autoimmune conditions. Management ranges from analgesics to physical therapy, local injections, hydrodilatation, and advanced surgical interventions. This study examines percutaneous coracohumeral ligament (PCHL) sectioning with the hypothesis that interruption would improve pain and ROM in patients with AC refractory to conservative management. 'Objectives: To use sonographically guided percutaneous interruption of the CHL for the treatment of refractory AC.Study Design: A prospective, randomized, controlled, cross-over trial. Setting: Academic medical center.Methods: Patients were identified based on inclusion and exclusion criteria under the supervision of the Principal Investigator. After primary screening, research staff explained the study, risks, and benefits to the patients, and consent was obtained. Patients' pain score and shoulder ROM were assessed before and after the procedure, at one month, and one year. The Oxford Shoulder Scoring (OSS) questionnaire was also completed before the procedure and in the one-year follow-up visit. Forty patients were enrolled with refractory AC. Forty-six shoulders were treated; 6 patients underwent a bilateral procedure. Block 2:1 randomization was performed for the 2 groups (PCHL release [PCHLR] and local anesthetic CHL [LACHL]). The LACHL group received a lidocaine injection at CHL, and the PCHLR group received the CHL using a Tenex (R) (Tenex Health, Lake Forest, CA) needle. ROM, Numeric Rating Scale (NRS-11), and OSS were evaluated at baseline, immediate postprocedure, and long term.Results: Among 46 shoulders included in the study, 7 were excluded due to lost to follow-up, total shoulder replacement, and shoulder manipulation. Twenty-six were randomized to the PCHLR group and 13 to LACHL group. ROM (external rotation and abduction), pain, NRS-11 score, and OSS score were measured at baseline and long term, confirmed by a nonbiased health care personnel. There was no statistically significant difference in ROM, NRS-11, and OSS between the 2 cohorts at the baseline visit. Nine patients in LACHL group crossed over to the PCHLR arm at one month. Data analysis in the long term revealed durability of the PCHLR group with a statistically significant difference in ROM, NRS-11, and OSS. External rotation improved by double, and abduction improved by almost 30% (P value < .001). NRS-11 decreased from 8 (IQR 8, 9) at baseline to 3 (IQR 2, 7) at long term among those who received PCHLR. The baseline mean OSS in the PCHLR group increased from 7.44 to 31.86 at one-year follow-up and was statistically significant (P value < .001).Limitations: This study represents a small population of patients with a CHL-related ROM deficit. Patients were not excluded for osteoarthritis or other motion-disabling shoulder conditions. We submit that the strength of the study could have been improved if the physician performing the procedure was blinded and if the patient was blinded as well to minimize operator and patient bias.Conclusions: We demonstrate that our technique for PCHLR is a safe, effective, and durable procedure that improved ROM, pain, and shoulder function in our patient population when compared to the control.