Percutaneous Coracohumeral Release for Patients with Adhesive Capsulitis: Two-Year Results from a Randomized Control Crossover Study.

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.

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® (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. KEY WORDS: Tenex, frozen shoulder, pain, range of motion, function, shoulder, minimally invasive, durable.