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Clinical Trial NCT06939530 (HYCAFVOL) for Capsulitis of Shoulder, Hydrodilatation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases. (HYCAFVOL) 64 Randomized

Recruiting
Clinical Trial NCT06939530 (HYCAFVOL) is an interventional study for Capsulitis of Shoulder, Hydrodilatation that is recruiting. It started on February 2, 2025 with plans to enroll 64 participants. Led by Javier Muñoz Paz, it is expected to complete by January 1, 2026. The latest data from ClinicalTrials.gov was last updated on April 23, 2025.
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), int...Show More
Official Title

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

Conditions
Capsulitis of ShoulderHydrodilatation
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • HYCAFVOL
NCT ID Number
NCT06939530
Start Date (Actual)
2025-02-02
Last Update Posted
2025-04-23
Completion Date (Estimated)
2026-01
Enrollment (Estimated)
64
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Adhesive Capsulitis
frozen shoulder
hydrodilatation
suprascapular nerve block
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorAdhesive 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
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 posterior...Show More
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 posterior...Show More
Active ComparatorAdhesive Capsulitis Phase 2
Adhesive Capsulitis Phase 2 --\> Patients in whom ROM limitation predominates in the face of pain.
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 posterior...Show More
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 posterior...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Shoulder pain and disability index (SPADI)
The Shoulder Pain Disability Index is a widely used outcome measure in studies that provides information about pain and limitation of shoulder pathologies. * Pain Scale How severe is the pain? 0 = no pain and 10 = the worst pain imaginable. * At its worst? * When lying on that side? * When reaching for something on a high shelf? * When touching the back of your neck? * When pushing with the affected arm? * Disability Scale: How much difficulty do you have? 0 = no pain and 10 = the worst pain imaginable. * Washing your hair. * Washing your back. * Putting on a T-shirt or sweater. * Putting on a button-down shirt. * Putting on your pants. * Placing an object on a high shelf. * Lifting a heavy object weighing 4.5 kilograms. * Taking something from his back pocket. Then, pain and disability are obtained separately, and a percentage of impairment is combined. This index has demonstrated "good internal consistency, convergent validity, and reliability" in its Spanish version.
Initial and 1 - 3 - 6 month after hydrodilatation
Visual Analgesic Scale (VAS)
The VAS "is a validated subjective measure for acute and chronic pain." It allows for the measurement of pain intensity with maximum reproducibility. It consists of a 10-centimeter horizontal line, with the extreme expressions of a symptom at each end. To the left (0) is the absence or lowest intensity, and to the right (10) is the highest intensity. The patient is asked to mark the point on the line that indicates the intensity. The minimally detectable differences for the symptom level to be acceptable are 2 to 3 points.
Initial and 1 - 3 - 6 month after hydrodilatation
Range of motion assessment (ROM)
Range of motion assessment is a basic practice in the study of shoulder pathologies, especially in the case of AC. ROM should be measured, both actively and passively. The ROMs that will be assessed actively and passively will primarily be flexion, abduction, external rotation (with the arm at 90° of abduction, by asking the patient to show us the palm of their hand), and internal rotation (with the arm at 90° of abduction, by asking the patient to show us the back of their hand). All of these are measured with the PLURIMETER inclinometer.
Initial and 1 - 3 - 6 month after hydrodilatation
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Axillary recess (AR) size
This will be measured using ultrasound with a longitudinal section of the AR. The patient will be placed supine with the shoulder abducted at 90° and the elbow flexed.
Initial
Time from star to end of physiotherapy
They will begin the PT program in less than 3-5 days. The PT start and start date will be scheduled according to pre-established criteria. The following criteria will be established for discontinuing PT treatment: * No improvement of 15% in ROM after full HD after 16 sessions. * Recovery of full ROM after 4 sessions. * Increased pain that makes PT impossible. * Maximum of 24 PT sessions. It will be measured in days.
From 1 session to a maximum of 3 months of PT
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
  • Ages between 30 and 70 years.
  • Limited ROM, both active and passive, in two planes.
  • Shoulder pain lasting more than 3 months.

  • 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.
Javier Muñoz Paz logoJavier Muñoz Paz
  • 🏛️Universid...
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Study Responsible Party
Javier Muñoz Paz, Sponsor-Investigator, Medical intern resident in physical medicine and rehabilitation, Maimónides Biomedical Research Institute of Córdoba
Study Central Contact
Contact: Javier Muñoz Paz, degree in medicine, 608737909, [email protected]
1 Study Locations in 1 Countries
Hospital Universitario Reina Sofia, Córdoba, 14004, Spain
Javier, Contact, 608737909
Recruiting