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NCT Number: NCT06509087

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.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tri-Service General Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Yi-Chih Hsu, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transarterial microembolization (TAME)

Procedure

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

Primary outcomes

  1. Pain relief

    Time frame: 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 outcomes

  1. Functional improvement (for shoulder joint)

    Time frame: 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.

  2. Functional improvement (for knee joint)

    Time frame: 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.

Other outcomes

  1. The technical success rate of TAME procedure

    Time frame: Immediately after the 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Chih Hsu, M.D.

CONTACT

[email protected]

+886-2-8792 3311 ext. 13661

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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