Clinical trial NCT06939530: Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
Official title: Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Capsulitis of Shoulder
Hydrodilatation
Keywords: Adhesive Capsulitis
frozen shoulder
hydrodilatation
suprascapular nerve block
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Universidad de Córdoba
name: Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)
name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2025-04-23
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ensayo clínico aleatorizado por bloques en paralelo con triple cegamiento.
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder pain and disability index (SPADI)
timeFrame: Initial and 1 - 3 - 6 month after hydrodilatation
measure: Visual Analgesic Scale (VAS)
timeFrame: Initial and 1 - 3 - 6 month after hydrodilatation
measure: Range of motion assessment (ROM)
timeFrame: Initial and 1 - 3 - 6 month after hydrodilatation
Secondary outcomes:
measure: Axillary recess (AR) size
timeFrame: Initial
measure: Time from star to end of physiotherapy
timeFrame: From 1 session to a maximum of 3 months of PT
Other outcomes:
measure: Lattinen Test
timeFrame: Initial and 1 - 3 - 6 month after hydrodilatation
measure: Patient Global Patient Improvement Impression Scale (PGI-I)
timeFrame: It will be measured at the last check-up 6 months after HD
measure: Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
timeFrame: It will be measured at the last check-up 6 months after HD
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
Study officials:
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Javier Muñoz Paz, degree in medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Fernando J Mayordomo Riera, Head of service
role: STUDY_DIRECTOR
affiliation: Universidad de Córdoba
name: Jose Peña Amaro, Professor of Histology - UCO
role: STUDY_DIRECTOR
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