Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment (TAE-FROST)

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

Status: Enrolling

Conditions: Adhesive Capsulitis of the Shoulder; Shoulder Adhesive Capsulitis; Frozen Shoulder

Treatments: Procedure: Transcatheter Arterial Micro- Embolization (TAME); Other: Usual care (conservative management)

Study type: Interventional

Funder types: Other

Identifiers

NCT07336849

2505-006-641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

Experimental: Transcatheter arterial micro-embolization (TAME)

Experimental group

Description:

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.

Treatment:

Procedure: Transcatheter Arterial Micro- Embolization (TAME)

Active Comparator: Usual care (conservative management)

Active Comparator group

Description:

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.

Treatment:

Other: Usual care (conservative management)