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

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ClinicalTrials.gov Identifier: NCT03168802
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Meng-Huang Wu, Taipei Medical University Hospital

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE April 21, 2017
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
Pain score change: Numerical Rating Scale (NRS) [ Time Frame: 24-week post-treatment ]
Efficacy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03168802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Pain score change: Numerical Rating Scale (NRS) [ Time Frame: 1-, 4-, 8-, 12-, 36-, 52-week post-treatment ]
    Efficacy
  • Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • Functional scales change: Oswestry Disability Questionnaire (ODQ) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • Functional scales change: Core Outcome Measurement Index (COMI) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • Functional scales change: EQ5D Quality of Life questionnaires [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • Amount of analgesic consumption [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • Adverse event [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2017)
  • Physical exams for back range of motion [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
  • X-ray for spine facet change [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
Official Title  ICMJE Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
50 patients in each arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Low Back Pain
  • Facet Joint Syndrome
Intervention  ICMJE
  • Procedure: MRgFUS ablation
    Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
  • Procedure: Radiofrequency ablation
    Radiofreuqency ablation therapy under C-arm navigation for facet joint syndrome.
Study Arms  ICMJE
  • Experimental: MRgFUS facet treatment
    MRgFUS ablation for facet joint pain once at Lumbar spine
    Intervention: Procedure: MRgFUS ablation
  • Active Comparator: Radiofreuqency ablation facet treatment
    Radiofreuqency ablation for facet joint pain once at Lumbar spine
    Intervention: Procedure: Radiofrequency ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meng-Huang Wu, MD 227372181 ext 3740 maxwutmu@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03168802
Other Study ID Numbers  ICMJE N201609021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Meng-Huang Wu, Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yen Yun, PhD Taipei Medical University
PRS Account Taipei Medical University Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP