Frozen Shoulder Clinical Trials

Find Frozen Shoulder Clinical Trials Near You

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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Chung-Ang Univerisity Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2025-09-18
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 44
Treatments
Experimental: Experimental: Transcatheter arterial micro-embolization (TAME)
Participants assigned to the experimental group will undergo a one-time transcatheter arterial micro-embolization (TAME) procedure using Nexsphere-F. Usual conservative management for shoulder pain (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided as part of standard clinical care based on clinical judgement and patient preference and is not mandated by the study protocol.
Active_comparator: Active Comparator: Usual care (conservative management)
Participants assigned to the control group will not undergo transcatheter arterial micro-embolization (TAME) and will receive usual conservative management for shoulder pain as part of standard clinical care. Conservative treatments (e.g., physical therapy, analgesic medications, and/or intra-articular hyaluronic acid injection) may be provided based on clinical judgement and patient preference and are not mandated by the study protocol.
Related Therapeutic Areas
Sponsors
Leads: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

This content was sourced from clinicaltrials.gov