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

Stanford University1 site in 1 countryOctober 2014

ConditionsLumbar Facet Joint Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lumbar Facet Joint Pain
Sponsor: Stanford University
Locations: 1
Primary Endpoint: Device Related Complications as a Measure of Safety
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

February 20, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Pejman Ghanouni

Assistant Professor of Radiology

Stanford University

Eligibility Criteria

Inclusion Criteria

•Men and women \> 21 years of age and who are skeletally mature
•Body mass index ≤ 30 kg/m2
•Patients who are able to understand and willing to sign a written informed consent document and able to attend all study visits
•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.
•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.
•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.
•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.
•The targeted facet joint must be deeper than 10 mm from the skin

Exclusion Criteria

•Patients with severe lumbar lordosis
•Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia. etc
•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
•Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
•Patients with known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
•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
•Patients with pain at another location that
•cannot be distinguished from lumbar back pain
•does not rate at least 2 points less in worst pain score compared to lumbar back pain
•requires the use of analgesics

Outcomes

Primary Outcomes

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.