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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorTri-Service General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transarterial microembolization (TAME)

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: TAME responder1 intervention
Group B: TAME non-responder1 intervention

Trial outcomes

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

Sponsors and contacts

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