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Enrolling by Invitation

NCT Number: NCT07599059

AI-Assisted Ultrasound Therapy for Adhesive Capsulitis

This study aims to integrate artificial intelligence with ultrasound imaging to investigate the dynamic biomechanical characteristics of adhesive capsulitis and to compare the therapeutic effectiveness of three ultrasound-guided hydrodilatation techniques: rotator interval injection, dual-target injection, and posterior glenohumeral injection. In the observational phase, healthy participants and patients with adhesive capsulitis will undergo static and dynamic ultrasound evaluations to quantify subacromial motion and the minimal vertical acromiohumeral distance (mvAHD) during shoulder abduction. A Faster R-CNN model will automatically identify the acromion and greater tuberosity to extract motion trajectories and frequency-based features.

In the randomized clinical trial phase, patients will be assigned to one of the three hydrodilatation techniques to compare improvements in pain, function, and range of motion at 6 and 12 weeks. All participants will subsequently enter a one-year follow-up to document recurrence, defined as the need for repeat intervention. Clinical characteristics, static sonographic parameters, dynamic motion metrics, and short-term treatment responses will be incorporated into machine-learning models to predict long-term outcomes, including recurrence risk. Eligible patients who decline randomization may consent to join a parallel observational cohort. They will receive standard-of-care treatment (conservative or interventional) based on their preference, and undergo the exact same baseline, Week 6, and Week 12 clinical and ultrasound assessments as the randomized trial participants.

The ultimate goal is to establish an AI-assisted predictive framework that enables individualized risk stratification, early identification of poor responders, and optimization of injection strategies. This model is expected to improve clinical decision-making, enhance treatment precision, and contribute to higher-quality patient care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Inclusion Criteria for the Control Group:
  • Age-matched adults (≥ 18 years old) with no symptoms of adhesive capsulitis.
  • Age distribution matched with that of the disease group.
  • Inclusion Criteria for the Disease Group (Adhesive Capsulitis):
  • Shoulder stiffness persisting for more than one month.
  • Restriction of passive range of motion by more than 30° in at least two of the three directions (forward flexion, abduction, and external rotation) compared to the contralateral side, with imaging findings consistent with the diagnostic features of primary adhesive capsulitis.

Exclusion criteria

  • Exclusion Criteria (for both Control and Disease Groups):
  • Systemic rheumatic disease (like rheumatoid arthritis and ankylosing spondylitis).
  • History of malignancy.
  • Previous major trauma, surgeries, or recent injection therapy on the affected shoulder.
  • Suprascapular nerve block within the previous three months.
  • Inability to clearly understand or express personal willingness due to central nervous system injury.

Treatment and study plan

Dual-Target Injection

Procedure

An ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa.

Rotator Interval Injection

Procedure

An ultrasound-guided injection administered through the rotator interval approach.

Posterior Recess Injection

Procedure

An injection into the glenohumeral joint utilizing a posterior approach.

Primary outcomes

  1. Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score

    Time frame: Baseline, Week 6, and Week 12

    Shoulder Pain and Disability Index:

    • Minimum and Maximum Values: 0 to 100
    • Higher scores mean a worse outcome (indicating more severe shoulder pain and a higher degree of disability).

Secondary outcomes

  1. Change from Baseline in Visual Analog Scale (VAS) for Pain

    Time frame: Baseline, Week 6, and Week 12

    Visual Analogue Scale:

    • Minimum and Maximum Values: 0 to 10 (often measured as 0 to 100 millimeters)
    • Higher scores mean a worse outcome (0 represents no pain at all, while 10 or 100 represents the worst imaginable pain).
  2. Change from Baseline in Shoulder Range of Motion (ROM)

    Time frame: Baseline, Week 6, and Week 12

  3. Incidence of Treatment-Related Adverse Events

    Time frame: Up to Week 12

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Artificial Intelligence-Assisted Dynamic Imaging Analysis and Predictive Modeling of Ultrasound-Guided Capsular Distension Therapy for Adhesive Capsulitis

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 20, 2026
Registry last updated
Jun 17, 2026

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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