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NCT Number: NCT06939530

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

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

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location status: Recruiting

Location contact

Javier

CONTACT

608737909

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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:

    • Pain intensity.
    • Pain frequency.
    • Analgesic use.
    • Degree of disability.
    • 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.

  2. 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".

  3. 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Muñoz Paz, degree in medicine

CONTACT

[email protected]

608737909 ext. +34

Sponsors and collaborators

Lead sponsor

Javier Muñoz Paz

Other

Collaborators

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

Registry information

Acronym: HYCAFVOL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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