MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

December 3, 2024 updated by: Meng-Huang Wu, Taipei Medical University Hospital

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

This is a prospective, randomized, two-arm, phase II study.

The purpose of this study is:

  • To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain.
  • Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment.
  • Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Please Select
      • Taipei, Please Select, Taiwan, 11031
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women age 20 to 79 years old
  2. Suffering from lumbar vertebral facet joint syndrome.
  3. Lower back pain at least six months (NRS≥4).
  4. Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
  5. Imaging of the spine have facet osteoarthritis.
  6. Referred pain is no more below the knee.
  7. At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction> 75% (0.5ml of 2% lidocaine).

Exclusion Criteria:

  1. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
  2. Patients with motor deficit or any other indication for surgical intervention.
  3. Patients with MRgFUS or RF treatment for LBP within the last 6 months.
  4. Patients with previous low back surgery.
  5. Patients who are pregnant.
  6. Patients with existing malignancy.
  7. Patients with allergies to relevant contrast, anesthetics, sedation drugs.
  8. Patients with contraindications for MRI.
  9. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.

  10. Patients with unstable cardiac status including:

    • Unstable angina pectoris on medication
    • Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
    • Patients with Severe Congestive Heart Failure, NYHA class 4.
    • Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
    • Patients with pacemaker
  11. Patients with severe cerebrovascular disease (CVA within last 6 months)
  12. Patients with severe hypertension (diastolic BP > 100 on medication)
  13. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  14. Patients unable to communicate with the investigator and staff.
  15. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
  16. Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
  17. When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MRgFUS facet treatment
MRgFUS ablation for facet joint pain once at Lumbar spine
Procedure: MRgFUS ablation
Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
Active Comparator: Radiofrequency ablation facet treatment
Radiofrequency ablation for facet joint pain once at Lumbar spine
Procedure: Radiofrequency ablation
Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain score change: Numerical Rating Scale (NRS)
Time Frame: 24-week post-treatment
Efficacy
24-week post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain score change: Numerical Rating Scale (NRS)
Time Frame: 1-, 4-, 8-, 12-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 36-, 52-week post-treatment
Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Oswestry Disability Questionnaire (ODQ)
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Core Outcome Measurement Index (COMI)
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: EQ5D Quality of Life questionnaires
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Amount of analgesic consumption
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Adverse event
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Safety
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical exams for back range of motion
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
X-ray for spine facet change
Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Efficacy
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yen Yun, PhD, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N201609021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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