Status:
COMPLETED
Cryoneurolysis for Facet Mediated Chronic Low Back Pain
Lead Sponsor:
Medical Pain Management Services, PLLC
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Low Back Pain
Facet Joint Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 media...
Detailed Description
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 media...
Eligibility Criteria
Inclusion
- 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
- 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:
- Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
- Infection
- Tumor
- Traumatic fracture
- Systemic inflammatory spondyloarthropathy
- Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)
- Neurogenic claudication
- Prior lumbar spinal fusion surgery
- Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
- Currently pregnant, nursing, or planning to become pregnant during the study
- Known contraindication to study devices, including any of the following:
- Cryoglobulinemia
- Paroxysmal cold hemoglobinuria
- Cold urticaria
- Raynaud's disease
- Open and/or infected wounds at or near the treatment site
- Coagulopathy
- 3.5-inch needle cannot be used in the low back region because of habitus
- Severe chronic pain disorder that in the opinion of the investigator may impact postsurgical outcomes
- Presence of any of the following:
- Spinal neurostimulator
- Intrathecal analgesic drug pump
- Current manifestation of poorly controlled mental illness that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:
- Mood disorder (e.g., major depression, bipolar)
- Psychotic disorder (e.g., schizophrenia)
- Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies)
- Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment
- History, suspicion, or clinical manifestation of:
- Alcohol abuse or dependence
- Illicit drug use
- Opioid abuse or dependence (≥40 mg MED PO/day in past 30 days) Given the COVID-19 pandemic, the subject must be medically fit/cleared for treatment by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for treatment due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded per Exclusion criterion #4.
Key Trial Info
Start Date :
June 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06016127
Start Date
June 18 2022
End Date
October 23 2023
Last Update
December 6 2024
Active Locations (1)
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1
The Albany & Saratoga Centers For Pain Management
Saratoga Springs, New York, United States, 12866