Nexsphere-F arterial embolization for chronic frozen shoulder pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chung-Ang Univerisity Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Woosun Choi, MD, PhD — Associate Professor
• Study coordinator: Woosun Choi, MD, PhD
• Email: radiochoi527@gmail.com
• Phone: +82-2-6299-2681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hormone Replacement Therapy added to standard care for frozen shoulder in peri- or postmenopausal women

  This study tests whether adding hormone replacement therapy to standard treatment helps reduce pain and stiffness from frozen shoulder in peri- or postmenopausal women.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07278323

• High-intensity interval training for persistent inflammatory shoulder pain

  This study will try short sessions of high-intensity interval training (HIIT) in adults with long-term shoulder pain thought to be driven by low-grade inflammation to see if the exercise is acceptable and whether inflammation and pain-related measures change.

  Recruiting Universiteit Antwerpen · Wilrijk · NCT07275164

• Evaluating non-invasive neurostimulation for frozen shoulder treatment

  This study is testing if a new non-invasive treatment using brain stimulation and tendon vibration can help people with frozen shoulder feel better compared to a placebo.

  Recruiting Université du Québec à Chicoutimi · Saguenay, Quebec · NCT06795932

• Spinal and Kaltenborn mobilization for a stiff shoulder (frozen shoulder)

  A randomized trial tests spinal mobilization with arm movement and Kaltenborn mobilization to see if they reduce pain and improve motion and function in people with adhesive capsulitis.

  Recruiting at 2 sites Riphah International University · Lahore, Punjab Province and 1 other locations · NCT07724691

• TaVNS added to physiotherapy for adhesive capsulitis

  This study tests whether adding a tVNS treatment to standard physiotherapy helps adults with adhesive capsulitis reduce pain and improve shoulder function.

  Recruiting Liv Hospital Vadistanbul · Istanbul, Istanbul · NCT07711353

• Shoulder Frozen Shoulder: TAME vs Corticosteroid Injection

  This study tests whether transcatheter arterial microembolization (TAME) works better than corticosteroid injections for people with frozen shoulder.

  Recruiting Shin Kong Wu Ho-Su Memorial Hospital · Taipei · NCT07696923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.