AI-Assisted Ultrasound Therapy for Adhesive Capsulitis

NCT07599059 | Enrolling By Invitation

• 1 other identifier: 202512151RIND
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis

Keywords

Adhesive capsulitis; artificial intelligence; dynamic ultrasound; subacromial motion; vertical acromiohumeral distance

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 6, and Week 12

Secondary Outcomes (3)

• 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

Study Arms (3)

Rotator Interval Injection

EXPERIMENTAL

Procedure: Rotator Interval Injection

Dual-Target Injecton

EXPERIMENTAL

Procedure: Dual-Target Injecton

Posterior Recess Injection

EXPERIMENTAL

Procedure: Posterior Recess Injection

Interventions

Dual-Target Injecton PROCEDURE

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

Dual-Target Injecton

Rotator Interval Injection PROCEDURE

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

Rotator Interval Injection

Posterior Recess Injection PROCEDURE

An injection into the glenohumeral joint utilizing a posterior approach.

Posterior Recess Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-04

Locations

TW (1)