Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain
Not yet recruitingNot applicableNCT06935539
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.
Study details
- Official title
- A Prospective, Single-center, Open-label, Pilot Randomized Controlled Study Evaluating the Clinical Effectiveness of Lateral Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Sacroiliac Joint Pain
- Conditions
- Chronic Sacroiliac Joint Pain
- Interventions
- Device: Cryoneurolysis
- Device: Radiofrequency ablation
- Sponsor
- Medical Pain Management Services, PLLC
- Collaborators
- Pacira Pharmaceuticals, Inc
- Start date
- 2025-05
- Primary completion
- 2026-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subjects at least 18 years of age at Screening 2. Primary complaint of buttock or axial low-back below L5 suggestive of unilateral or bilateral SIJ-mediated back pain 3. Positive SIJ provocative testing (at least two tests must be positive) 1. Thigh thrust test 2. Distraction test 3. Gaenslen's test 4. Compression test 5. Sacral thrust test 4. Low back or buttock pain is chronic (i.e., ≥ 3 months' duration) 5. Low back or buttock pain is moderate to severe (score of ≥ 4 to ≤ 9) on the 0 to 10 NRS at Screening 6. Low back or buttock pain causes functional impairment (≥ 30% on ODI) at Screening 7. 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 8. 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) 9. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment Exclusion Criteria: 1. Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine 2. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following: 1. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction) 2. Infection 3. Tumor 4. Traumatic fracture 5. Systemic inflammatory spondyloarthropathy 6. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit) 7. Neurogenic claudication 3. Prior SIJ fusion surgery across the SI joint 4. 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 5. Currently pregnant, nursing, or planning to become pregnant during the study 6. Known contraindication to study device, including any of the following: 1. Cryoglobulinemia 2. Paroxysmal cold hemoglobinuria 3. Cold urticaria 4. Raynaud's disease 5. Open and/or infected wounds at or near the treatment site 6. Coagulopathy 7. Previous participation in an iovera° study 8. Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes 9. Presence of any of the following: 1. Spinal neurostimulator 2. Intr…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06935539