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

Javier Muñoz Paz

Status: Enrolling

Conditions: Capsulitis of Shoulder; Hydrodilatation

Treatments: Procedure: Hydrodilatation (40 ml); Procedure: Hydrodilatation (20 ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT06939530

HYCAFVOL

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages between 30 and 70 years.
• Limited ROM, both active and passive, in two planes.
• Shoulder pain lasting more than 3 months.

Exclusion criteria

• Lidocaine + trial with improved ROM.
• Conditions that preclude treatment (active cancer, tissue infection, oral anticoagulant use, cardiac arrhythmias, etc.)
• Previously receiving HD treatment in less than 1 year.
• Stage 0 or 3 AC.
• Non-adherence to the PT program, with attendance failures exceeding 20%.
• Presence of conditions that can cause similar symptoms, such as acromioclavicular osteoarthritis, labral injury, massive rotator cuff tear, or rheumatic diseases.
• Intra-articular corticosteroid injection in less than 2 months.
• Technique failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Adhesive Capsulitis Phase 1

Active Comparator group

Description:

Adhesive Capsulitis Phase 1 --\> Patients in phase 1 will be considered as those in which the predominant clinical picture is pain accompanied by limitation of ROM

Treatment:

Procedure: Hydrodilatation (20 ml)

Procedure: Hydrodilatation (40 ml)

Adhesive Capsulitis Phase 2

Active Comparator group

Description:

Adhesive Capsulitis Phase 2 --\> Patients in whom ROM limitation predominates in the face of pain.

Treatment:

Procedure: Hydrodilatation (20 ml)

Procedure: Hydrodilatation (40 ml)