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

NCT06939530 | Recruiting

• 1 other identifier: HYCAFVOL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Capsulitis of Shoulder; Hydrodilatation

Keywords

Adhesive Capsulitis; frozen shoulder; hydrodilatation; suprascapular nerve block

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Axillary recess (AR) size

  Initial

• Time from star to end of physiotherapy

  From 1 session to a maximum of 3 months of PT

Other Outcomes (3)

• Lattinen Test

  Initial and 1 - 3 - 6 month after hydrodilatation

• Patient Global Patient Improvement Impression Scale (PGI-I)

  It will be measured at the last check-up 6 months after HD

• Global CGI - GI Impression of Global Improvement Scale (CGI - GI)

  It will be measured at the last check-up 6 months after HD

Study Arms (2)

Adhesive Capsulitis Phase 1

ACTIVE COMPARATOR

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

Procedure: Hydrodilatation (20 ml); Procedure: Hydrodilatation (40 ml)

Adhesive Capsulitis Phase 2

ACTIVE COMPARATOR

Adhesive Capsulitis Phase 2 --\> Patients in whom ROM limitation predominates in the face of pain.

Procedure: Hydrodilatation (20 ml); Procedure: Hydrodilatation (40 ml)

Interventions

Hydrodilatation (20 ml) PROCEDURE

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.

Adhesive Capsulitis Phase 1; Adhesive Capsulitis Phase 2

Hydrodilatation (40 ml) PROCEDURE

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 1; Adhesive Capsulitis Phase 2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 30 and 70 years.
• Limited ROM, both active and passive, in two planes.
• Shoulder pain lasting more than 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Javier Muñoz Paz: lead
• Universidad de Córdoba: collaborator
• Maimonides Institute for Biomedical Research of Cordoba (IMIBIC): collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Related Publications (41)

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Related Links

• Frozen shoulder adhesive capsulitis - UpToDate
• Physical examination of the shoulder- UpToDate

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Javier Muñoz Paz, degree in medicine

  Hospital Universitario Reina Sofia de Cordoba

  PRINCIPAL INVESTIGATOR

• Fernando J Mayordomo Riera, Head of service

  Hospital Universitario Reina Sofia de Cordoba

  STUDY DIRECTOR

• Jose Peña Amaro, Professor of Histology - UCO

  Universidad de Córdoba

  STUDY DIRECTOR

Central Study Contacts

Javier Muñoz Paz, degree in medicine

CONTACT

608737909; javimp1395@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For this trial, we propose triple blinding. The principal investigator, Javier Muñoz, will be the only one aware of the treatment assignment. Neither the patient, the reviewer, the physiotherapists, nor the statistician will be aware of the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical intern resident in physical medicine and rehabilitation

Model Details: Ensayo clínico aleatorizado por bloques en paralelo con triple cegamiento.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 23, 2025
• Study Start: February 2, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)