๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค 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
โฅ Patients with a known hypersensitivity to contrast media
โฆ Patients who are pregnant or breastfeeding
โง Patients with a localized infection at the pain site
โจ Patients deemed inappropriate for participation by the investigator due to ethical concerns or potential impact on the clinical trial results
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What it tests
- Transcatheter Arterial Micro- Embolization (TAME)
- Usual care (conservative management)
Chung-Ang Univerisity Hospital
Seoul, South Korea
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.