Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment

NCT07336849 | Recruiting

• 1 other identifier: 2505-006-641
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frozen Shoulder; Shoulder Adhesive Capsulitis; Adhesive Capsulitis of the Shoulder

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) score

  Change from baseline in shoulder pain severity assessed using the Visual Analog Scale (VAS) score, a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain.

  Baseline and 6 months after the procedure

Secondary Outcomes (6)

• Visual Analog Scale (VAS) scores at early follow-up

  Baseline, 1 week, 1 month, and 3 months after the procedure

• Shoulder joint range of motion (ROM)

  Baseline, and at 1 week, 1 month, 3 months, and 6 months after the procedure

• American Shoulder and Elbow Surgeons (ASES) score

  Baseline and 6 months after the procedure

• Single Assessment Numeric Evaluation (SANE)

  Baseline and 6 months after the procedure

• Patient satisfaction with treatment

  6 months after the procedure

Study Arms (2)

Experimental: Transcatheter arterial micro-embolization (TAME)

EXPERIMENTAL

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.

Procedure: Transcatheter Arterial Micro- Embolization (TAME)

Active Comparator: Usual care (conservative management)

ACTIVE COMPARATOR

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.

Other: Usual care (conservative management)

Interventions

Usual care (conservative management) OTHER

Usual conservative management for shoulder pain provided 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 or standardized by the study protocol.

Active Comparator: Usual care (conservative management)

Transcatheter Arterial Micro- Embolization (TAME) PROCEDURE

A one-time transcatheter arterial micro-embolization (TAME) procedure will be performed via radial artery access. After angiographic identification of abnormal neovascularity or hypervascular lesions associated with shoulder pain, target vessels will be superselected with a microcatheter and embolized using Nexsphere-F (gelatin-based bioresorbable embolic particles) until angiographic stasis or marked reduction of abnormal hyperemia is achieved, according to operator judgement.

Experimental: Transcatheter arterial micro-embolization (TAME)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead
• Next Biomedical Co., Ltd.: collaborator

Study Sites (1)

Chung-Ang Univerisity Hospital

Seoul, 06973, South Korea

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 13, 2026
• Study Start: September 18, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

KR (1)