Status:
NOT_YET_RECRUITING
Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain
Lead Sponsor:
Medical Pain Management Services, PLLC
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Chronic Sacroiliac Joint Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized ...
Detailed Description
This is a single-center, randomized, pilot study in adult subjects with chronic SIJ pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneur...
Eligibility Criteria
Inclusion
- Subjects at least 18 years of age at Screening
- Primary complaint of buttock or axial low-back below L5 suggestive of unilateral or bilateral SIJ-mediated back pain
- Positive SIJ provocative testing (at least two tests must be positive)
- Thigh thrust test
- Distraction test
- Gaenslen's test
- Compression test
- Sacral thrust test
- Low back or buttock pain is chronic (i.e., ≥ 3 months' duration)
- Low back or buttock pain is moderate to severe (score of ≥ 4 to ≤ 9) on the 0 to 10 NRS at Screening
- Low back or buttock pain causes functional impairment (≥ 30% on ODI) at Screening
- Successful trial of one diagnostic sacroiliac joint block with local anesthetic and steroids that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used
- 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 appropriate analgesics)
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment
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 SIJ fusion surgery across the SI joint
- 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
- Previous participation in an iovera° study
- 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
- 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:
- a. Mood disorder (e.g., depression, bipolar) i. Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening b. Psychotic disorder (e.g., schizophrenia) c. Catastrophizing i. Pain Catastrophizing Scale (PCS) score \>30 at Screening
- Subject received other spine interventions/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 ≤ 6 months before study enrollment at the intended treatment levels
- 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 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 medically fit/cleared for surgery 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 :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06935539
Start Date
May 1 2025
End Date
August 1 2026
Last Update
April 20 2025
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