WithdrawnNot Applicable

MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain

Stopped: No patients met eligibility.

United States0Started 2014-10

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Device Related Complications as a Measure of Safety

Timeframe: 24 months

Trial details

NCT IDNCT02291978

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-20

View on ClinicalTrials.gov More Lumbar Facet Joint Pain trials