AI-Assisted Ultrasound Therapy for Adhesive Capsulitis

Artificial Intelligence-Assisted Dynamic Imaging Analysis and Predictive Modeling of Ultrasound-Guided Capsular Distension 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Procedure: Rotator Interval Injection; Procedure: Dual-Target Injecton; Procedure: Posterior Recess Injection

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital, Bei-Hu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion Criteria for the Control Group:

  1. Age-matched adults (≥ 18 years old) with no symptoms of adhesive capsulitis.
  2. Age distribution matched with that of the disease group.

• Inclusion Criteria for the Disease Group (Adhesive Capsulitis):

  1. Shoulder stiffness persisting for more than one month.
  2. 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):

  1. Systemic rheumatic disease (like rheumatoid arthritis and ankylosing spondylitis).
  2. History of malignancy.
  3. Previous major trauma, surgeries, or recent injection therapy on the affected shoulder.
  4. Suprascapular nerve block within the previous three months.
  5. Inability to clearly understand or express personal willingness due to central nervous system injury.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotator Interval Injection	Procedure: Rotator Interval Injection; An ultrasound-guided injection administered through the rotator interval approach.
Experimental: Dual-Target Injecton	Procedure: Dual-Target Injecton; An ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa.
Experimental: Posterior Recess Injection	Procedure: Posterior Recess Injection; An injection into the glenohumeral joint utilizing a posterior approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score	Baseline, Week 6, and Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Visual Analog Scale (VAS) for Pain	Baseline, Week 6, and Week 12
Change from Baseline in Shoulder Range of Motion (ROM)	Baseline, Week 6, and Week 12
Incidence of Treatment-Related Adverse Events	Up to Week 12

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: artificial intelligence; Adhesive capsulitis; dynamic ultrasound; subacromial motion; vertical acromiohumeral distance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: 202512151RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No