Actively Recruiting
A Single-center, Prospective, Open Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Arterial Embolization Using Nexsphere-F in Patients with Adhesive Capsulitis of the Shoulder Joint Refractory to Conservative Treatment
Led by Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Updated on 2026-05-19
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Lead Sponsor
N
Next Biomedical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of transcatheter arterial embolization using a material called Nexsphere-F for relieving pain in patients with adhesive capsulitis of the shoulder joint, commonly known as frozen shoulder, who have not improved with standard treatments. This single-center, prospective, open-label, randomized clinical trial aims to better understand this procedure's impact on shoulder pain and function. Participants in this trial are randomly assigned to one of two groups. The experimental group will receive a one-time transcatheter arterial micro-embolization (TAME) procedure using Nexsphere-F, which involves blocking certain blood vessels in the shoulder to reduce pain. The control group will continue with usual conservative care, such as physical therapy, pain medications, or local injections, based on clinical judgment and patient preference. Both groups will be monitored and evaluated over time. Throughout the study, participants will have their pain measured using the Visual Analog Scale (VAS) at several points: before the procedure and at 1 week, 1 month, 3 months, and 6 months afterward. Additional assessments include shoulder range of motion (ROM), American Shoulder and Elbow Surgeons (ASES) scores, Single Assessment Numeric Evaluation (SANE) scores, and patient satisfaction surveys. Magnetic resonance imaging (MRI) scans of the shoulder will be taken before the procedure and at 6 months to observe structural changes. Follow-up evaluations will be conducted through hospital visits or telephone interviews over a 6-month period.
CONDITIONS
Brief Title
Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 19 and 85 years
- Patients who have signed informed consent after explanation of the trial
- Patients with shoulder pain persisting for more than 3 months despite physical therapy, analgesics, or local injections
- Patients with a shoulder joint range of motion (ROM) less than 90 degrees
- Patients who agree not to use other conservative treatments beyond those allowed (physical therapy, NSAIDs, opioid analgesics, acetaminophen, intra-articular hyaluronic acid)
- Patients willing to comply with treatment, procedures, and all follow-up evaluations by visits or telephone
You will not qualify if you...
- Patients with a history of surgery on the affected shoulder joint
- Patients suspected to have a full-thickness rotator cuff tear
- Patients with bleeding disorders or coagulopathies
- Patients with advanced atherosclerosis or vasospasm in arm vessels or expected to have these conditions
- Patients with known hypersensitivity to gelatin
- Patients with known hypersensitivity to contrast media
- Patients who are pregnant or breastfeeding
- Patients with a localized infection at the pain site
- Patients deemed inappropriate for participation by the investigator due to ethical concerns or potential impact on trial results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - One-time procedure and ongoing usual care as needed
Participants assigned to the experimental group undergo a one-time transcatheter arterial micro-embolization (TAME) procedure using Nexsphere-F. Participants in the control group receive usual conservative management for shoulder pain as part of standard clinical care. Conservative treatments may include physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection based on clinical judgement and patient preference.
1 procedure visit (in-person) for TAME; conservative care visits as part of routine healthcare
Duration - 6 months
Participants are followed for pain levels and shoulder function through outpatient visits or telephone interviews at multiple time points post-procedure. Assessments include pain scales (Visual Analog Scale), shoulder range of motion, functional scores, patient satisfaction, and MRI imaging to evaluate structural changes.
Outpatient visits or telephone interviews at baseline, 1 week, 1 month, 3 months, and 6 months post-procedure; MRI performed before procedure and at 6 months
Trial Site Locations
Total: 1 location
1
Chung-Ang Univerisity Hospital
Seoul, South Korea, 06973
Actively Recruiting
Research Team
W
Woosun Choi, MD, PhD
J
Jinyoung Choi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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