Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

NCT06935539 | Not Yet Recruiting FDA Device

• 1 other identifier: CRS-131
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.

Conditions

Chronic Sacroiliac Joint Pain

Keywords

low back pain; chronic low back pain; sacroiliac joint pain; chronic sacroiliac joint pain; cryoneurolysis; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Safety and Clinical Effectiveness of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)

  Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.

  0-12 months

Secondary Outcomes (7)

• Pain Intensity

  0-12 Months

• Functional disability

  0-12 months

• Concomitant medication use

  0-12 months

• Success and failure rate of study interventions

  Day 180

• Shor-form 12 (SF-12)

  Screening, Day 90 (± 5 days), Day 180 (± 5 days), Day 270 (± 7 days), Day 360 (± 7 days)

Other Outcomes (1)

• Lost work days

  0-12 months

Study Arms (2)

Cryoneurolysis

ACTIVE COMPARATOR

Subjects will receive iovera° cryoneurolysis to the nerves of the sacroiliac joint

Device: Cryoneurolysis

Radiofrequency ablation

ACTIVE COMPARATOR

Subjects will receive RFA to nerves of the sacroiliac joint

Device: Radiofrequency ablation

Interventions

Cryoneurolysis DEVICE

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 "STT21180STIM" Smart Tip will be used in this study.

Also known as: iovera

Cryoneurolysis

Radiofrequency ablation DEVICE

Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Pain Management Services, PLLC: lead
• Pacira Pharmaceuticals, Inc: collaborator

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Martin Ferrillo, DO

  The Albany & Saratoga Centers For Pain Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasandra Cliff, MSN, RN

CONTACT

518-371-6772; khopkins@northwayspc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to treatment groups according to the randomization assignment

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL