Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

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

Overview

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.

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 cryoneurolysis or radiofrequency ablation (RFA).

This study is designed to evaluate the clinical effectiveness of iovera° cryoneurolysis in adult subjects with chronic SIJ pain. Furthermore, the study will assess the feasibility of the outcome measurements employed, construct a foundation for sample size calculation, and the acceptability/practicality of conducting an efficacy randomized controlled trial (RCT).

Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment.

Interventions

• Device Cryoneurolysis
  The iovera° system consists of a reusable, portable Handpiece, along with single-patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The
• Device Radiofrequency ablation
  Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

Primary outcome measures

• Safety and Clinical Effectiveness of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) [Time frame: 0-12 months]

Secondary outcome measures (7)

• Pain Intensity [Time frame: 0-12 Months]
• Functional disability [Time frame: 0-12 months]
• Concomitant medication use [Time frame: 0-12 months]
• Success and failure rate of study interventions [Time frame: Day 180]
• Shor-form 12 (SF-12) [Time frame: Screening, Day 90 (± 5 days), Day 180 (± 5 days), Day 270 (± 7 days), Day 360 (± 7 days)]
• Satisfaction With Pain Management [Time frame: 12 months]
• Patients' Global Impression of Change [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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 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:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Birkenmaier C, Veihelmann A, Trouillier H, Hausdorf J, Devens C, Wegener B, Jansson V, von Schulze Pellengahr C. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial. Int Orthop. 2007 Aug;31(4):525-30. doi: 10.1007/s00264-006-0208-6. Epub 2006 Aug 23. PMID 16927087

Identifiers

NCT: NCT06935539 · CRS-131

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗