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

Official title

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.

Overview

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.

Interventions

• Procedure 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.
• Other 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.

Primary outcome measures

• Visual Analog Scale (VAS) score [Time frame: Baseline and 6 months after the procedure]

Secondary outcome measures (6)

• Visual Analog Scale (VAS) scores at early follow-up [Time frame: Baseline, 1 week, 1 month, and 3 months after the procedure]
• Shoulder joint range of motion (ROM) [Time frame: Baseline, and at 1 week, 1 month, 3 months, and 6 months after the procedure]
• American Shoulder and Elbow Surgeons (ASES) score [Time frame: Baseline and 6 months after the procedure]
• Single Assessment Numeric Evaluation (SANE) [Time frame: Baseline and 6 months after the procedure]
• Patient satisfaction with treatment [Time frame: 6 months after the procedure]
• Structural changes of the shoulder joint assessed by magnetic resonance imaging (MRI) [Time frame: Baseline and 6 months after the procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Chung-Ang Univerisity Hospital — Seoul

Identifiers

NCT: NCT07336849 · 2505-006-641

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗