About this trial

Evaluation of the efficacy and safety of transcatheter arterial embolization using 'Nexsphere-F' for pain relief in patients with adhesive capsulitis of the shoulder joint that does not respond to conservative treatment.

This study aims to investigate the efficacy and safety of transcatheter arterial embolization using embolic agents in patients with adhesive capsulitis of the shoulder joint. This is a single-center, prospective, open-label, randomized clinical trial.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcatheter Arterial Micro- Embolization (TAME)
  • Usual care (conservative management)

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

1
Chung-Ang Univerisity Hospital06973, Seoul South Korea

Sponsors and collaborators

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Lead sponsor

Next Biomedical Co., Ltd.

Collaborator