Effects of Hydrodilatation at Different Volumes on Adhesive Capsulitis in Phases 1 and 2: Clinical Trial Protocol HYCAFVOL.

Abstract

Background: Adhesive capsulitis (AC) causes a global limitation of both active and passive range of motion (ROM) in the shoulder, with or without pain, and no specific radiographic findings. Its course is self-limiting and progresses through three or four stages. The diagnosis is primarily clinical, since imaging tests are nonspecific. Treatment options include physical therapy (PT), intra-articular corticosteroid injections, suprascapular nerve block (SSNB), and hydrodilatation (HD). The latter is useful for expanding and reducing inflammation of the joint capsule through the insufflation of saline solution, anesthetics, and corticosteroids. Objectives: To compare whether patients with AC, stratified by phase 1 and 2, who receive high-volume HD as treatment achieve better outcomes in terms of shoulder pain and function compared to patients who receive low-volume HD. To compare whether there are differences in PT times and to determine mean axillary recess (AR) values. Methods: A randomized, parallel-block, triple-blind clinical trial will be conducted in 64 patients with AC in phases 1 and 2, aged 30 to 70 years, with limited active and passive ROM in two planes, and shoulder pain lasting more than 3 months. HD will be administered with volumes of 20 mL or 40 mL, followed by a conventional rehabilitation program. Outcomes will be reviewed at the 1st, 3rd, and 6th months of HD. Variables collected will include Shoulder Pain and Disability Index (SPADI), Visual Analog Scale (VAS), Range of motion (ROM), Lattinen index (LI), AR size, and time to completion of PT. Results: HD has been gaining clinical relevance in interventional rehabilitation as a treatment for AC, although its medium- and long-term efficacy remains a matter of debate. The variability in the volumes used for capsular expansion, with studies ranging from 18 mL to 47 mL, is compounded by the fact that most of these studies do not differentiate between AC stages. This could influence treatment effectiveness. Furthermore, diagnosis remains a challenge since valid and specific diagnostic parameters are lacking. Conclusions: Understanding the differences between HD techniques, considering the influence of certain factors such as the volume used or the stages of AC, as well as improving diagnosis and the coordination of scientific work. This could facilitate the development of protocols for the use of HD in AC.