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

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: Recruiting
• Conditions: Chronic Low Back Pain; Facet Joint Syndrome
• Intervention / Treatment: Procedure: MRgFUS ablation; Procedure: Radiofrequency ablation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng-Huang Wu, MD; Phone Number: 3740 227372181; Email: maxwutmu@gmail.com

Study Locations

• Taiwan
  • Please Select
    • Taipei, Please Select, Taiwan, 11031
      • Recruiting
      • Taipei Medical University Hospital
      • Contact: Meng-Huang Wu, MD; Phone Number: 3740 227372181; Email: maxwutmu@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain score change: Numerical Rating Scale (NRS)	Efficacy	24-week post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score change: Numerical Rating Scale (NRS)	Efficacy	1-, 4-, 8-, 12-, 36-, 52-week post-treatment
Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Oswestry Disability Questionnaire (ODQ)	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Core Outcome Measurement Index (COMI)	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: EQ5D Quality of Life questionnaires	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Amount of analgesic consumption	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Adverse event	Safety	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical exams for back range of motion	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
X-ray for spine facet change	Efficacy	1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Study Chair: Yen Yun, PhD, Taipei Medical University

Publications and helpful links

General Publications

• Weeks EM, Platt MW, Gedroyc W. MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain--case series of an innovative new technique. Eur Radiol. 2012 Dec;22(12):2822-35. doi: 10.1007/s00330-012-2628-6. Epub 2012 Aug 31.
• Kaye EA, Monette S, Srimathveeravalli G, Maybody M, Solomon SB, Gulati A. MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia. 2016 Nov;32(7):786-94. doi: 10.1080/02656736.2016.1197972. Epub 2016 Jul 21.
• Krug R, Do L, Rieke V, Wilson MW, Saeed M. Evaluation of MRI protocols for the assessment of lumbar facet joints after MR-guided focused ultrasound treatment. J Ther Ultrasound. 2016 Apr 6;4:14. doi: 10.1186/s40349-016-0057-8. eCollection 2016.
• Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Estimated): November 25, 2025
• Study Completion (Estimated): November 25, 2025

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Chronic low back pain; Radiofrequency Ablation; Focused ultrasound Ablation; Facet joint syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Back Pain; Osteoarthritis; Low Back Pain
• Other Study ID 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