The Combined Utility of Angio-CT and MRI in Managing Chronic Musculoskeletal Pain: a Prospective Study to Evaluate the Efficacy of Transarterial Microembolization

Recruiting

• Conditions: Transarterial Embolization; Magnetic Resonance Imaging; Angiography; Computed Tomography; Chronic Musculoskeletal Disease
• Interventions: Procedure: Transarterial microembolization (TAME)

• Registration Number: NCT06509087
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

Transarterial microembolization (TAME) is a novel treatment option for chronic musculoskeletal pain, especially suitable for patients who have not responded to conservative treatment or are unsuitable for surgical procedures. This minimally invasive technique primarily targets abnormal neovascularization for embolization, relying heavily on precise information provided by various imaging techniques to ensure the effectiveness and safety of the treatment. This study aims to explore the application of integrating preoperative magnetic resonance imaging (MRI) evidence of patient pain and intraoperative high-resolution synchronous imaging information from fused computed tomography (CT) and angiography systems. This integration is intended to enhance preoperative planning, intraoperative guidance, and final treatment outcome assessment, focusing on its crucial contribution to treatment success. It is hoped that this approach will provide pain intervention physicians with reliable diagnostic tools and safe treatment methods, thereby improving treatment outcomes for patients with chronic musculoskeletal pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-19
• Study Start: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with chronic musculoskeletal shoulder or knee joint pain in our hospital, including degenerative knee arthritis, adhesive capsulitis of the shoulder, and those confirmed by physical examination or ultrasound-guided injection to have tendinopathy or ligamentopathy, who have failed drug therapy, rehabilitation, or injection treatments, with a duration of symptoms greater than three months, are the target population of this study.

Exclusion Criteria

• Pregnancy, coagulation disorders, symptoms of relevant local infections or tumors, and patients allergic to contrast agents. Patients must have complete medical records; those who do not meet the inclusion criteria will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAME non-responder	Transarterial microembolization (TAME)	Transarterial microembolization (TAME) is performed on all included patients with chronic shoulder or knee joint pain. Non-responders are determined if pain score reduction is less than two points or if pain score increases based on the Visual Analogue Scale (VAS) at 1-month follow-up after the TAME.
TAME responder	Transarterial microembolization (TAME)	Transarterial microembolization (TAME) is performed on all included patients with chronic shoulder or knee joint pain. Responders are determined if pain score reduction is two points or more based on the Visual Analogue Scale (VAS) at 1-month follow-up after the TAME.

Primary Outcome Measures

Name	Time	Method
Pain relief	day 0, day 1, week 1, month 1, month 3, and month 6.	Pain relief is measured according to the Visual Analog Scale (VAS) immediately prior to (baseline) and after the TAME procedure (day 0) as well as day 1, week 1, month 1, month 3, and month 6.

Secondary Outcome Measures

Name	Time	Method
Functional improvement (for shoulder joint)	day 0, day 1, week 1, month 1, month 3, and month 6.	Functional improvement is measured according to Shoulder Pain and Disability Index (SPADI) for patients with chronic shoulder pain immediately prior (baseline) to and after the TAME procedure (day 0) as well as day 1, week 1, month 1, month 3, and month 6.
Functional improvement (for knee joint)	day 0, day 1, week 1, month 1, month 3, and month 6.	Functional improvement is measured according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) for patients with chronic knee pain immediately prior (baseline) to and after the TAME procedure (day 0) as well as day 1, week 1, month 1, month 3, and month 6.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan