Adhesive CapsulitisNCT07599059
AI-Assisted Ultrasound Therapy for Adhesive Capsulitis
A study testing Dual-Target Injection, Rotator Interval Injection and Posterior Recess Injection in people with Adhesive Capsulitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Dual-Target Injection, Rotator Interval Injection and Posterior Recess Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Dual-Target Injection, Rotator Interval Injection, Posterior Recess Injection
- Keywords
- Adhesive Capsulitis, Artificial Intelligence, Dynamic Ultrasound, Subacromial Motion, Vertical Acromiohumeral Distance
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Target InjectionProcedure or surgery
An ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa.
Rotator Interval InjectionProcedure or surgery
An ultrasound-guided injection administered through the rotator interval approach.
Posterior Recess InjectionProcedure or surgery
An injection into the glenohumeral joint utilizing a posterior approach.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Interval Injection | Experimental | Not described Receives: Procedure: Rotator Interval Injection |
| Dual-Target Injecton | Experimental | Not described Receives: Procedure: Dual-Target Injection |
| Posterior Recess Injection | Experimental | Not described Receives: Procedure: Posterior Recess Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score
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).
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (3)
Change from Baseline in Visual Analog Scale (VAS) for Pain
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).
Measured: Baseline, Week 6, and Week 12
Change from Baseline in Shoulder Range of Motion (ROM)
Measured: Baseline, Week 6, and Week 12
Incidence of Treatment-Related Adverse Events
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599059
- Sponsor's protocol ID
- 202512151RIND
- Status last verified
- Apr 2026
- First submitted
- 14 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Dynamic Imaging Analysis and Predictive Modeling of Ultrasound-Guided Capsular Distension Therapy for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07599059
- Acronym / sponsor ID
- 202512151RIND
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Artificial Intelligence, Dynamic Ultrasound, Subacromial Motion, Vertical Acromiohumeral Distance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rotator Interval Injection | Experimental | Procedure: Rotator Interval Injection |
| Dual-Target Injecton | Experimental | Procedure: Dual-Target Injection |
| Posterior Recess Injection | Experimental | Procedure: Posterior Recess Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inclusion Criteria for the Disease Group (Adhesive Capsulitis):
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Target InjectionAn ultrasound-guided injection targeting both the rotator interval and the subdeltoid bursa. | Procedure or surgery | Dual-Target Injecton |
| Rotator Interval InjectionAn ultrasound-guided injection administered through the rotator interval approach. | Procedure or surgery | Rotator Interval Injection |
| Posterior Recess InjectionAn injection into the glenohumeral joint utilizing a posterior approach. | Procedure or surgery | Posterior Recess Injection |
Primary outcome
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: 1. Minimum and Maximum Values: 0 to 100 2. Higher scores mean a worse outcome (indicating more severe shoulder pain and a higher degree of disability).
3 secondary outcomes
Change from Baseline in Visual Analog Scale (VAS) for Pain
Time frame: Baseline, Week 6, and Week 12
Change from Baseline in Shoulder Range of Motion (ROM)
Time frame: Baseline, Week 6, and Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Target Injection, Rotator Interval Injection and Posterior Recess Injection in people with Adhesive Capsulitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Shoulder Pain and Disability Index (SPADI) Total Score (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.