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Compares treatment options for Low Back Pain, Chronic
Official title A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain
ClinicalTrials.gov ID: NCT07214844
What this study is testing
- What it's testing
- A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold to certain nerves in the lower back. The other is the standard treatment called radiofrequency ablation, which uses heat.
- Time commitment: about 12 months
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all of the following to be eligible for participation:
- people at least 18 years of age at Screening
- Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative...
- Low back pain is chronic (i.e., ≥ 3 months' duration)
- Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
You likely can't join if
- people who meet any of the following exclusion criteria will not be eligible for participation in this study:
- 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
See the full eligibility criteria
- people must meet all of the following to be eligible for participation:
- people at least 18 years of age at Screening
- Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
- Low back pain is chronic (i.e., ≥ 3 months' duration)
- Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
- Low back pain causes functional impairment (≥ 30% on ODI) 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 80% relief of primary (index) pain for the duration of...
- Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other...
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment
- people who meet any of the following exclusion criteria will not be eligible for participation in this study:
- 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 at the intended treatment levels
- 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 device, 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
- Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes
- Presence of any of the following:
- Spinal neurostimulator
- Intrathecal analgesic drug pump
- Cardiac implantable device
- Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:
- Mood disorder (e.g., depression, bipolar) Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening
- Psychotic disorder (e.g., schizophrenia)
- Catastrophizing Patient Catastrophizing Scale (PCS) score \> 30 at Screening
- Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels
- Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels
- Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., \> 24 hours)
- History, suspicion, or clinical manifestation of:
- Alcohol abuse or dependence
- Illicit drug use
- Opioid abuse or dependence (≥40 mg medication PO/day in past 30 days)
- Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery 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...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.