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

April 18, 2025 updated by: Javier Muñoz Paz

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Javier Muñoz Paz, degree in medicine
  • Phone Number: +34 608737909
  • Email: javimp1395@gmail.com

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Javier
          • Phone Number: 608737909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: 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.

Procedure: 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.
Active Comparator: Adhesive Capsulitis Phase 2
Adhesive Capsulitis Phase 2 --> Patients in whom ROM limitation predominates in the face of pain.
Procedure: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability index (SPADI)
Time Frame: Initial and 1 - 3 - 6 month after hydrodilatation

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)
Time Frame: Initial and 1 - 3 - 6 month after hydrodilatation

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)
Time Frame: Initial and 1 - 3 - 6 month after hydrodilatation

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 Measure
Measure Description
Time Frame
Axillary recess (AR) size
Time Frame: Initial
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
Time Frame: From 1 session to a maximum of 3 months of PT

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lattinen Test
Time Frame: Initial and 1 - 3 - 6 month after hydrodilatation

The Lattinen test is a widely used tool for assessing pain, validated in Spain as a tool to measure the degree of pain in patients with chronic pain. This scale consists of five items scored from 0 to 4:

  1. Pain intensity.
  2. Pain frequency.
  3. Analgesic use.
  4. Degree of disability.
  5. Hours of sleep.

Although this test is widely used in chronic pain conditions, its use in AC is not very common. However, we believe it can provide important data such as analgesic medication intake. This is why we consider its use appropriate.
Initial and 1 - 3 - 6 month after hydrodilatation
Patient Global Patient Improvement Impression Scale (PGI-I)
Time Frame: It will be measured at the last check-up 6 months after HD
The PGI-I consists of a single question that asks the patient to classify the relief obtained with the treatment according to a 7-point Likert scale: "much better"; "much better"; "a little better"; "no change"; "a little worse"; "much worse"; "much worse".
It will be measured at the last check-up 6 months after HD
Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
Time Frame: It will be measured at the last check-up 6 months after HD
The CGI-I, the physician compares the patient's initial clinical condition with the current condition: "Compared to the patient's condition at the time of admission to the project [prior to the start of medication], this patient's condition is: 1=much better since the start of treatment; 2=much improved; 3=minimally improved; 4=no change since baseline (the start of treatment); 5=minimally worse; 6=much worse; 7=much worse since the start of treatment."
It will be measured at the last check-up 6 months after HD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javier Muñoz Paz

Collaborators

Hospital Universitario Reina Sofia de Cordoba
Universidad de Córdoba
Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)

Investigators

  • Principal Investigator: Javier Muñoz Paz, degree in medicine, Hospital Universitario Reina Sofía de Córdoba
  • Study Director: Fernando J Mayordomo Riera, Head of service, Hospital Universitario Reina Sofía de Córdoba
  • Study Director: Jose Peña Amaro, Professor of Histology - UCO, Universidad de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYCAFVOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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