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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

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Facet Joint Syndrome Procedure: MRgFUS ablation Procedure: Radiofrequency ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 50 patients in each arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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: Radiofreuqency ablation facet treatment
Radiofreuqency ablation for facet joint pain once at Lumbar spine
Procedure: Radiofrequency ablation
Radiofreuqency ablation therapy under C-arm navigation for facet joint syndrome.




Primary Outcome Measures :
  1. Pain score change: Numerical Rating Scale (NRS) [ Time Frame: 24-week post-treatment ]
    Efficacy


Secondary Outcome Measures :
  1. Pain score change: Numerical Rating Scale (NRS) [ Time Frame: 1-, 4-, 8-, 12-, 36-, 52-week post-treatment ]
    Efficacy

  2. Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  3. Functional scales change: Oswestry Disability Questionnaire (ODQ) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  4. Functional scales change: Core Outcome Measurement Index (COMI) [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  5. Functional scales change: EQ5D Quality of Life questionnaires [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  6. Amount of analgesic consumption [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  7. Adverse event [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Safety


Other Outcome Measures:
  1. Physical exams for back range of motion [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy

  2. X-ray for spine facet change [ Time Frame: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment ]
    Efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168802


Contacts
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Contact: Meng-Huang Wu, MD 227372181 ext 3740 maxwutmu@gmail.com

Locations
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Taiwan
Taipei medical university hospital Recruiting
Taipei, Please Select, Taiwan, 11031
Contact: Meng-Huang Wu, MD    227372181 ext 3740    maxwutmu@gmail.com   
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
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Study Chair: Yen Yun, PhD Taipei Medical University

Publications:
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Responsible Party: Meng-Huang Wu, Principal Investigator, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03168802     History of Changes
Other Study ID Numbers: N201609021
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Meng-Huang Wu, Taipei Medical University Hospital:
Focused ultrasound Ablation
Radiofrequency Ablation
Facet joint syndrome
Chronic low back pain

Additional relevant MeSH terms:
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Osteoarthritis
Back Pain
Low Back Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms