Clinical Trial

Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.

Study acronym: HYCAFVOL
Recruiting
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Record status
This record was last updated April 23, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
Adhesive capsulitis (AC) causes a global limitation of active and passive range of motion (ROM) in the shoulder, with or without pain, and no other radiographic findings. The natural process is self-limiting, evolving in three or four phases. It is common in women around 50 years of age. Diagnosis is based on clinical symptoms, with imaging tests being 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 insufflation with saline solution, anesthetics, and corticosteroids. Objectives: To determine whether patients with AC, stratified by phase, who receive high-volume HD therapy achieve better outcomes in the Shoulder Pain and Disability Index (SPADI), Analgesic Analogue Scale (VAS), and ROM at the first, third, and sixth months of therapy compared to patients who receive low-volume HD. To determine whether there are differences in FST times and to determine mean axilar recess (AR) values. Methods: A randomized, triple-blind, parallel-block 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 physical therapy program. Outcomes will be reviewed at the first, third, and sixth months of HD. Variables collected will include SPADI, VAS, ROM, Lattinen assessment, AR size, and time to completion of PT
Trial Details
NCT Number NCT06939530
Lead Sponsor Javier Muñoz Paz
Collaborators: Universidad de Córdoba, Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Hospital Universitario Reina Sofia de Cordoba
Conditions Capsulitis of Shoulder, Hydrodilatation
Enrollment 64 participants
Start Date 2025-02-02
Primary Completion 2026-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-23