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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• Ages between 30 and 70 years.

• Limited ROM, both active and passive, in two planes.

• Shoulder pain lasting more than 3 months.

Locations
Other Locations
Spain
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Contact Information
Primary
Javier Muñoz Paz, degree in medicine
javimp1395@gmail.com
608737909
Time Frame
Start Date: 2025-02-02
Estimated Completion Date: 2026-01
Participants
Target number of participants: 64
Treatments
Active_comparator: Adhesive Capsulitis Phase 1
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
Active_comparator: Adhesive Capsulitis Phase 2
Adhesive Capsulitis Phase 2 --\> Patients in whom ROM limitation predominates in the face of pain.
Related Therapeutic Areas
Sponsors
Collaborators: Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Universidad de Córdoba, Hospital Universitario Reina Sofia de Cordoba
Leads: Javier Muñoz Paz

This content was sourced from clinicaltrials.gov