MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain

NCT02291978 | Withdrawn DMC

• 1 other identifier: 29163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Facet Joint Pain

Keywords

back pain; facet joint; spine

Outcome Measures

Primary Outcomes (1)

• Device Related Complications as a Measure of Safety

  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.

  24 months

Secondary Outcomes (2)

• Pain Relief on the Visual Analog Scale

  24 months

• Quality of Life Improvement

  24 months

Study Arms (1)

ExAblate 2100 Treatment

EXPERIMENTAL

The ExAblate 2100 system will be used in the MRgHIFU treatment of lower back pain arising from facet joint arthritis.

Device: ExAblate 2100

Interventions

ExAblate 2100 DEVICE

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.

ExAblate 2100 Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with gross spinal instability on imaging
• Patients who have lumbar spinal stabilization hardware in place
• Target is:
• NOT visible by non-contrast MRI, OR
• NOT accessible to ExAblate device

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pejman Ghanouni, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 17, 2014
• Study Start: October 1, 2014
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)