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

NCT03168802 | Recruiting

• 1 other identifier: N201609021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Focused ultrasound Ablation; Radiofrequency Ablation; Facet joint syndrome; Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Pain score change: Numerical Rating Scale (NRS)

  Efficacy

  24-week post-treatment

Secondary Outcomes (7)

• Pain score change: Numerical Rating Scale (NRS)

  1-, 4-, 8-, 12-, 36-, 52-week post-treatment

• Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

• Functional scales change: Oswestry Disability Questionnaire (ODQ)

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

• Functional scales change: Core Outcome Measurement Index (COMI)

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

• Functional scales change: EQ5D Quality of Life questionnaires

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Other Outcomes (2)

• Physical exams for back range of motion

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

• X-ray for spine facet change

  1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Study Arms (2)

MRgFUS facet treatment

EXPERIMENTAL

MRgFUS ablation for facet joint pain once at Lumbar spine

Procedure: MRgFUS ablation

Radiofrequency ablation facet treatment

ACTIVE COMPARATOR

Radiofrequency ablation for facet joint pain once at Lumbar spine

Procedure: Radiofrequency ablation

Interventions

MRgFUS ablation PROCEDURE

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

MRgFUS facet treatment

Radiofrequency ablation PROCEDURE

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

Radiofrequency ablation facet treatment

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei medical university hospital

Taipei, Please Select, 11031, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 22935902 BACKGROUND

• 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.

  PMID: 27443328 BACKGROUND

• 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.

  PMID: 27054038 BACKGROUND

• 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.

  PMID: 26495910 BACKGROUND

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yen Yun, PhD

  Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Meng-Huang Wu, MD

CONTACT

227372181; maxwutmu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 50 patients in each arm.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 30, 2017
• Study Start: August 24, 2018
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)