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RecruitingNCT06509087Updated Aug 28, 2024

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

An observational study in Chronic Musculoskeletal Disease, Transarterial Embolization and Magnetic Resonance Imaging, sponsored by Tri-Service General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Tri-Service General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Musculoskeletal Disease
  • Transarterial Embolization
  • Magnetic Resonance Imaging
  • Angiography
  • Computed Tomography
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureTransarterial microembolization (TAME)

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

05

What researchers measure

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.

    Time frame: day 0, day 1, week 1, month 1, month 3, and month 6.

Secondary outcomes

  1. 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.

    Time frame: day 0, day 1, week 1, month 1, month 3, and month 6.

  2. 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.

    Time frame: day 0, day 1, week 1, month 1, month 3, and month 6.

Other outcomes

  1. 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.

    Time frame: Immediately after the TAME procedure

06

Study locations

1 of 1 sites recruiting
  • Tri-Service General Hospital
    Taipei, Taiwan
    • Yi-Chih Hsu, M.D. · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06509087
Lead sponsor
Tri-Service General Hospital
Responsible party
yi-chih HSU (Attending doctor, Tri-Service General Hospital) — Principal investigator
First posted
Jul 19, 2024
Start date
Jul 25, 2024
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Aug 28, 2024

Study contacts

Yi-Chih Hsu, M.D.
Contact
doc31578@gmail.com
+886-2-8792 3311 ext. 13661
Yi-Chih Hsu, M.D.
principal investigator · Tri-Service General Hospital, National Defense Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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