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

NCT ID: NCT07336849

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2027-08-31

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.

Detailed Description

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.

Pain levels will be assessed via outpatient visits or telephone interviews at baseline (pre-procedure), and at 1 week, 1 month, 3 months, and 6 months post-procedure. During outpatient visits, the Visual Analog Scale (VAS), American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, shoulder range of motion (ROM), and the patient's subjective satisfaction (satisfied or not) will be recorded. Magnetic resonance imaging (MRI) of the shoulder joint will be performed both before the procedure and at 6 months post-procedure in both the control and intervention groups for comparative evaluation.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcatheter Arterial Micro- Embolization (TAME)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care (conservative management)

Intervention Type: 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.

Interventions

Transcatheter Arterial Micro- Embolization (TAME)

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.

Intervention Type: PROCEDURE

Usual care (conservative management)

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Woosun Choi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chung-Ang Univerisity Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Woosun Choi, MD. Ph D.

Role: primary

radiochoi527@cauhs.or.kr

+82-10-2223-5073

Other Identifiers

2505-006-641

Identifier Type: -

Identifier Source: org_study_id