Comparing results of different volumes of hydrodilatation for frozen shoulder
Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
This study is testing whether using more or less fluid in a treatment for frozen shoulder helps people feel better and move their shoulder more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba Academic / other |
| Locations | 1 site (Córdoba) |
| Trial ID | NCT06939530 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of high-volume versus low-volume hydrodilatation in patients with adhesive capsulitis, also known as frozen shoulder. Participants will be stratified by the phase of their condition and will receive either 20 ml or 40 ml of hydrodilatation treatment. Outcomes will be measured using the Shoulder Pain and Disability Index (SPADI), Visual Analogue Scale (VAS), and range of motion (ROM) assessments at one, three, and six months post-treatment. The goal is to determine which volume of hydrodilatation yields better results in alleviating symptoms and improving shoulder function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 70 with limited shoulder range of motion and pain lasting more than three months.
Not a fit: Patients with conditions that mimic adhesive capsulitis or those who have had recent treatments that may affect their shoulder function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating adhesive capsulitis, leading to improved patient outcomes and reduced pain.
How similar studies have performed: Previous studies have shown varying success with hydrodilatation for adhesive capsulitis, but this specific comparison of volume is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Córdoba
- Hospital Universitario Reina Sofia — Córdoba, Spain (Recruiting)
Study contacts
- Principal investigator: Javier Muñoz Paz, degree in medicine — Hospital Universitario Reina Sofia de Cordoba
- Study coordinator: Javier Muñoz Paz, degree in medicine
- Email: javimp1395@gmail.com
- Phone: 608737909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.