Actively Recruiting

Phase Not Applicable
Age: 20Years - 79Years
All Genders
NCT03168802

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

Led by Taipei Medical University Hospital · Updated on 2024-12-05

100

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women age 20 to 79 years old
  • Diagnosed with lumbar vertebral facet joint syndrome
  • Have had lower back pain for at least six months with a pain score of 4 or higher on the Numerical Rating Scale
  • Have tried conventional pain treatments such as NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, or chiropractic therapy
  • Imaging shows facet osteoarthritis in the spine
  • Referred pain does not extend below the knee
  • Experienced at least 75% pain relief from local anesthesia or diagnostic medial nerve branch injection with 0.5ml of 2% lidocaine
Not Eligible

You will not qualify if you...

  • Evidence of lumbosacral radiculopathy on MRI, CT, or physical exam, including radicular leg pain
  • Presence of motor deficits or any need for surgical intervention
  • Received MRgFUS or radiofrequency treatment for low back pain within the last 6 months
  • Previous low back surgery
  • Pregnancy
  • Existing malignancy
  • Allergies to relevant contrast agents, anesthetics, or sedation drugs
  • Contraindications for MRI
  • Acute medical conditions such as pneumonia or sepsis that may prevent study completion
  • Unstable cardiac conditions including unstable angina on medication, myocardial infarction within 40 days, severe congestive heart failure (NYHA class 4), use of anti-arrhythmic drugs, uncontrolled arrhythmia, or pacemaker
  • Severe cerebrovascular disease (stroke within last 6 months)
  • Severe hypertension with diastolic blood pressure over 100 despite medication
  • Active infections or severe uncontrolled hematological, neurological, or other diseases
  • Inability to communicate with study staff
  • Unable or unwilling to tolerate approximately 2 hours in a stationary position during treatment
  • Coagulation or bleeding disorders, or use of anticoagulants or antiplatelet drugs within 5 days before treatment
  • Less than 75% pain relief following local anesthesia or diagnostic medial nerve branch injection with 0.5ml of 2% lidocaine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Taipei medical university hospital

Taipei, Please Select, Taiwan, 11031

Actively Recruiting

Loading map...

Research Team

M

Meng-Huang Wu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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