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

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

Conditions

• Capsulitis of Shoulder
• Hydrodilatation

Interventions

PROCEDURE

Hydrodilatation (20 ml)

First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml.

PROCEDURE

Hydrodilatation (40 ml)

First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml.

Sponsors & Collaborators

• Universidad de Córdoba

  collaborator OTHER

• Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)

  collaborator UNKNOWN

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Javier Muñoz Paz

  lead OTHER

Principal Investigators

• Javier Muñoz Paz, degree in medicine · Hospital Universitario Reina Sofia de Cordoba

• Fernando J Mayordomo Riera, Head of service · Hospital Universitario Reina Sofia de Cordoba

• Jose Peña Amaro, Professor of Histology - UCO · Universidad de Córdoba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-02

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• Spain

Study Locations