Chronic Musculoskeletal DiseaseNCT06509087
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 of Chronic Musculoskeletal Disease and Transarterial Embolization, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Disease, Transarterial Embolization, Magnetic Resonance Imaging
- What is being tested?
- Transarterial microembolization (TAME)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jul 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei
Yi-Chih Hsu, M.D.
About this study
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
- Being tested
- Transarterial microembolization (TAME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial microembolization (TAME)Procedure or surgery
TAME primarily targets abnormal neovascularization for embolization in chronic shoulder or knee joint pain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Transarterial microembolization (TAME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0, day 1, week 1, month 1, month 3, and month 6.
Secondary outcomes (2)
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.
Measured: 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.
Measured: day 0, day 1, week 1, month 1, month 3, and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start25 Jul 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yi-chih HSU, Tri-Service General Hospital (TSGH)
- Investigators
- Yi-Chih Hsu, M.D., Principal investigator, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509087
- Sponsor's protocol ID
- C202405040
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao WC, Huang HY, Chen YH, Huang HB, Liaw WJ, Hsu YC. Nonselective Intra-arterial CT Angiography Versus Selective Digital Subtraction Angiography for Detecting Neovascularization During Transarterial Embolization for Adhesive Capsulitis. Cardiovasc Intervent Radiol. 2026 Jul 29. doi: 10.1007/s00270-026-04533-0. Online ahead of print.
PubMed 42527615
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Utility of Angio-CT and MRI in Managing Chronic Musculoskeletal Pain: a Prospective Study to Evaluate the Efficacy of Transarterial Microembolization
- ClinicalTrials.gov ID
- NCT06509087
- Acronym / sponsor ID
- C202405040
- Conditions
- Chronic Musculoskeletal Disease, Transarterial Embolization, Magnetic Resonance Imaging, Angiography, Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAME responder | – | Procedure: Transarterial microembolization (TAME)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. |
| TAME non-responder | – | Procedure: Transarterial microembolization (TAME)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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial microembolization (TAME)TAME primarily targets abnormal neovascularization for embolization in chronic shoulder or knee joint pain. | Procedure or surgery | TAME non-responder, TAME responder |
Primary outcome
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.
2 secondary outcomes
Functional improvement (for shoulder joint)
Time frame: day 0, day 1, week 1, month 1, month 3, and month 6.
Functional improvement (for knee joint)
Time frame: day 0, day 1, week 1, month 1, month 3, and month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 42527615Liao WC, Huang HY, Chen YH, Huang HB, Liaw WJ, Hsu YC. Nonselective Intra-arterial CT Angiography Versus Selective Digital Subtraction Angiography for Detecting Neovascularization During Transarterial Embolization for Adhesive Capsulitis. Cardiovasc Intervent Radiol. 2026 Jul 29. doi: 10.1007/s00270-026-04533-0. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Chih Hsu, M.D. principal investigator
Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Musculoskeletal Disease and Transarterial Embolization, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chih Hsu, M.D. (+886-2-8792 3311 ext. 13661, doc31578@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: day 0, day 1, week 1, month 1, month 3, and month 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.