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

Official title

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

Overview

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.

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.

Primary outcome measures

• Pain score change: Numerical Rating Scale (NRS) [Time frame: 24-week post-treatment]

Secondary outcome measures (7)

• Pain score change: Numerical Rating Scale (NRS) [Time frame: 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]
• Functional scales change: Oswestry Disability Questionnaire (ODQ) [Time frame: 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]
• Functional scales change: EQ5D Quality of Life questionnaires [Time frame: 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]
• Adverse event [Time frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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
• Patients with severe cerebrovascular disease (CVA within last 6 months)
• Patients with severe hypertension (diastolic BP > 100 on medication)
• Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
• Patients unable to communicate with the investigator and staff.
• Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
• Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
• When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Taipei medical university hospital — Taipei

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. PMID 22935902
• 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
• 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
• 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

Identifiers

NCT: NCT03168802 · N201609021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗