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

NCT03168802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Low Back Pain
  • Facet Joint Syndrome

Interventions

PROCEDURE

MRgFUS ablation

Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.

PROCEDURE

Radiofrequency ablation

Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

Sponsors & Collaborators

  • Taipei Medical University Hospital

    lead OTHER

Principal Investigators

  • Yen Yun, PhD · Taipei Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168802 on ClinicalTrials.gov