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Trial record 1 of 1 for:    NCT02291978
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MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain

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ClinicalTrials.gov Identifier: NCT02291978
Recruitment Status : Withdrawn (No patients met eligibility.)
First Posted : November 17, 2014
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Pejman Ghanouni, Stanford University

Tracking Information
First Submitted Date  ICMJE November 5, 2014
First Posted Date  ICMJE November 17, 2014
Last Update Posted Date February 24, 2020
Study Start Date  ICMJE October 2014
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
Device Related Complications as a Measure of Safety [ Time Frame: 24 months ]
Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Device Related Complications as a Measure of Safety [ Time Frame: 24 months ]
    Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
  • Pain Relief on the Visual Analog Scale and Quality of Life Improvement [ Time Frame: 24 months ]
    Effectiveness will be determined by the level of pain relief, as measured by the NRS, decrease in analgesic/opiate use, and improved quality of life, as measured by the Oswestry Disability Index.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • Pain Relief on the Visual Analog Scale [ Time Frame: 24 months ]
    Effectiveness will be determined by the level of pain relief, as measured by the NRS, and decrease in analgesic/opiate use.
  • Quality of Life Improvement [ Time Frame: 24 months ]
    Effectiveness will be determined by improved quality of life, as measured by the Oswestry Disability Index.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain
Official Title  ICMJE A Feasibility Study to Evaluate the Safety and Initial Effectiveness of MR Guided High Intensity Focused Ultrasound (MRgHIFU) in the Treatment of Facetogenic Lumbar Back Pain
Brief Summary The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of facetogenic lower back pain.
Detailed Description This is a single group, single arm, open/nonblinded, non-randomized study. The primary outcomes are safety and preliminary efficacy. The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.The study will reach primary completion 12 months from the time the study opens to accrual.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Facet Joint Pain
Intervention  ICMJE Device: ExAblate 2100
The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.
Study Arms  ICMJE Experimental: ExAblate 2100 Treatment
The ExAblate 2100 system will be used in the MRgHIFU treatment of lower back pain arising from facet joint arthritis.
Intervention: Device: ExAblate 2100
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 20, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2014)
10
Actual Study Completion Date  ICMJE February 20, 2020
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women > 21 years of age and who are skeletally mature
  2. Body mass index ≤ 30 kg/m2
  3. Patients who are able to understand and willing to sign a written informed consent document and able to attend all study visits
  4. Patients with at least 6 months of chronic lower back pain (LBP) localized to the midline or axial low back, with symptoms attributed to the facet joints on physical examination that have persisted despite conservative therapy. Conservative therapy is defined as systemic pain medications and anti-inflammatory medications, as well as physical therapy, such as massage, heating, hydrotherapy, and strengthening exercises.
  5. Patients with Numerical Rating Scale worst lumbar back pain score of at least 4 out of 10 over the 24 hours preceding the time of rating.
  6. Patients must have chronic LBP attributed to facet joints as demonstrated by MRI consistent with at least grade 2 facet joint arthritis, with corresponding abnormal activity at the facet joint on 18F-sodium fluoride PET-CT.
  7. Patients must have an analgesic response to either prior local anesthetic injection to the facet joint or to radiofrequency ablation of the facet joint, with relapse of pain.
  8. The targeted facet joint must be deeper than 10 mm from the skin

Exclusion Criteria:

  1. Patients with severe lumbar lordosis
  2. Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia. etc
  3. Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
  4. Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
  5. Patients with known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
  6. Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain, or any neurologic deficit at or below the segmental level of the highest facet to be treated, including subjects with impaired sphincter control
  7. Patients with pain at another location that

    1. cannot be distinguished from lumbar back pain
    2. does not rate at least 2 points less in worst pain score compared to lumbar back pain
    3. requires the use of analgesics
  8. Patients with gross spinal instability on imaging
  9. Patients who have lumbar spinal stabilization hardware in place
  10. Target is:

    • NOT visible by non-contrast MRI, OR
    • NOT accessible to ExAblate device
  11. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 5 hrs of total table time)
  12. Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
  13. Patients with unstable cardiac status including:

    1. Unstable angina pectoris on medication
    2. Patients with documented myocardial infarction within six months of protocol entry
    3. Congestive heart failure requiring medication (other than diuretic)
    4. Patients on anti-arrhythmic drugs
  14. Patients with severe hypertension (diastolic BP > 100 on medication)
  15. Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets < 50,000/microL, INR > 1.5)
  16. Patients who are taking anti-thrombotic medication
  17. Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)
  18. Patients with inflammatory arthritides.
  19. Patients unable to communicate with the investigator and staff
  20. Patients seeking compensation for disability or work injury.
  21. Patients who are part of another trial testing other Investigational Agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291978
Other Study ID Numbers  ICMJE 29163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pejman Ghanouni, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pejman Ghanouni, MD, PhD Stanford University
PRS Account Stanford University
Verification Date February 2020

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