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

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Computed Tomography; Chronic Musculoskeletal Disease; Angiography; Transarterial Embolization
• Intervention / Treatment: Procedure: Transarterial microembolization (TAME)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yi-Chih Hsu, M.D.; Phone Number: 13661 +886-2-8792 3311; Email: doc31578@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Yi-Chih Hsu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with chronic musculoskeletal shoulder or knee joint pain who undergo preoperative magnetic resonance imaging (MRI) and receive transarterial microembolization (TAME) performed using fused computed tomography (CT) and angiography systems.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAME responder; 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.	Procedure: Transarterial microembolization (TAME); TAME primarily targets abnormal neovascularization for embolization in chronic shoulder or knee joint pain.
TAME non-responder; 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.	Procedure: Transarterial microembolization (TAME); TAME primarily targets abnormal neovascularization for embolization in chronic shoulder or knee joint pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	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.	day 0, day 1, week 1, month 1, month 3, and month 6.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement (for shoulder joint)	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.	day 0, day 1, week 1, month 1, month 3, and month 6.
Functional improvement (for knee joint)	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.	day 0, day 1, week 1, month 1, month 3, and month 6.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The technical success rate of TAME procedure	The technical success rate is judged according to the digital subtraction angiography (DSA). A successful procedure is determined by decreased neovascularization via targeted vessels embolization by the fused CT and angiography system.	Immediately after the TAME procedure

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Yi-Chih Hsu, M.D., Tri-Service General Hospital, National Defense Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Pain; Musculoskeletal Diseases
• Other Study ID Numbers: C202405040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No