Nexsphere-F arterial embolization for chronic frozen shoulder pain
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.
We will try a minimally invasive arterial embolization using Nexsphere-F to reduce pain in adults with frozen shoulder that hasn’t improved with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Chung-Ang University Hosptial, Chung-Ang University College of Medicine Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07336849 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, open-label randomized trial compares transcatheter arterial micro-embolization (TAME) using Nexsphere-F against continued conservative management in patients with adhesive capsulitis refractory to prior therapy. Participants are randomized to receive either TAME or usual care and are followed for 6 months with visits or telephone calls at 1 week, 1 month, 3 months, and 6 months. Outcomes include pain (VAS), functional scores (ASES, SANE), shoulder range of motion, patient satisfaction, and MRI changes at baseline and 6 months. Safety and adverse events are monitored during and after the procedure.
Who should consider this trial
Good fit: Adults aged 19–85 with adhesive capsulitis lasting more than 3 months, limited shoulder ROM (<90°), and persistent pain despite physical therapy, medications, or injections are the intended participants.
Not a fit: Patients who have recently improved with conservative care, have shoulder pain from other identifiable causes (such as rotator cuff tear or infection), or who cannot undergo embolization for medical reasons are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could reduce shoulder pain and improve range of motion, potentially decreasing the need for repeated injections or surgery.
How similar studies have performed: Small case series and early single-center reports of arterial embolization for shoulder conditions and related tendinopathies have shown promising pain and function improvements, but randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients who have voluntarily signed a written informed consent form after receiving an explanation of the purpose, methods, and potential effects of the clinical trial
* Patients aged between 19 and 85 years
* Patients with pain persisting for more than 3 months in the affected area and with a history of receiving physical therapy, analgesics/anti-inflammatory medications, or local injection treatments
* Patients with a measured shoulder joint range of motion (ROM) of less than 90 degrees ⑤ Patients who agree not to receive any conservative treatment other than those permitted in this clinical trial (physical therapy, medication \[NSAIDs, opioid analgesics, acetaminophen\], intra-articular injections such as hyaluronic acid)
* Patients who are willing to comply with the treatment and procedures of the clinical trial and participate in all follow-up evaluations through hospital visits or telephone surveys
Exclusion Criteria:
* Patients with a history of surgery on the shoulder joint targeted for the clinical trial prior to screening
* Patients suspected of having a full-thickness rotator cuff tear
* Patients with bleeding disorders or coagulopathies (e.g., idiopathic thrombocytopenic purpura, hemophilia, disseminated intravascular coagulation)
* Patients with advanced atherosclerosis or vasospasm in the arm vessels, or those expected to have such conditions
* Patients with a known hypersensitivity to gelatin
⑥ Patients with a known hypersensitivity to contrast media
⑦ Patients who are pregnant or breastfeeding
⑧ Patients with a localized infection at the pain site
⑨ Patients deemed inappropriate for participation by the investigator due to ethical concerns or potential impact on the clinical trial results
Where this trial is running
Seoul
- Chung-Ang Univerisity Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.