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

NCT06509087 | Recruiting

• 1 other identifier: C202405040
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Disease; Transarterial Embolization; Magnetic Resonance Imaging; Angiography; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional improvement (for shoulder joint)

  day 0, 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.

Other Outcomes (1)

• The technical success rate of TAME procedure

  Immediately after the TAME procedure

Study Arms (2)

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 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)

Interventions

Transarterial microembolization (TAME) PROCEDURE

TAME primarily targets abnormal neovascularization for embolization in chronic shoulder or knee joint pain.

TAME non-responder; TAME responder

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Yi-Chih Hsu, M.D.

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chih Hsu, M.D.

CONTACT

+886-2-8792 3311; doc31578@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: July 25, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)