Cryoneurolysis for Facet Mediated Chronic Low Back Pain (NCT06016127) | Clinical Trial Compass
CompletedNot Applicable
Cryoneurolysis for Facet Mediated Chronic Low Back Pain
United States30 participantsStarted 2022-06-18
Plain-language summary
This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female volunteers, at least 18 years of age at screening
✓. Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP)
✓. Low back pain is chronic (i.e., \> 3 months' duration)
✓. Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment at screening
✓. Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used or history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months prior to enrollment)
✓. Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics),
✓. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
Exclusion criteria
✕. Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
✕. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following: