Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
NCT ID: NCT06939530
Last Updated: 2025-04-23
Study Results
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Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2025-02-02
2026-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml.
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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml.
Adhesive 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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml.
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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml.
Interventions
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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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml.
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 posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml.
Eligibility Criteria
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Inclusion Criteria
* Limited ROM, both active and passive, in two planes.
* Shoulder pain lasting more than 3 months.
Exclusion Criteria
* 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.
30 Years
70 Years
ALL
No
Sponsors
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Universidad de Córdoba
OTHER
Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)
UNKNOWN
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Javier Muñoz Paz
OTHER
Responsible Party
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Javier Muñoz Paz
Medical intern resident in physical medicine and rehabilitation
Principal Investigators
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Javier Muñoz Paz, degree in medicine
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Reina Sofia de Cordoba
Fernando J Mayordomo Riera, Head of service
Role: STUDY_DIRECTOR
Hospital Universitario Reina Sofia de Cordoba
Jose Peña Amaro, Professor of Histology - UCO
Role: STUDY_DIRECTOR
Universidad de Córdoba
Locations
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Hospital Universitario Reina Sofia
Córdoba, , Spain
Countries
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Central Contacts
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Facility Contacts
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Javier
Role: primary
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: INFORMED CONSENT AND PATIENT INFORMATION SHEET
Related Links
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Other Identifiers
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HYCAFVOL
Identifier Type: -
Identifier Source: org_study_id
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