Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

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

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 Overview

• Status: Not yet recruiting
• Conditions: Chronic Sacroiliac Joint Pain
• Intervention / Treatment: Device: Cryoneurolysis; Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kasandra Cliff, MSN, RN; Phone Number: 204 518-371-6772; Email: khopkins@northwayspc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Intrathecal analgesic drug pump

10. 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

11. 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
12. Subject received radiofrequency ablation ≤ 6 months before study enrollment at the intended treatment levels

13. History, suspicion, or clinical manifestation of:

    1. Alcohol abuse or dependence
    2. Illicit drug use
    3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryoneurolysis; Subjects will receive iovera° cryoneurolysis to the nerves of the sacroiliac joint	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 "STT21180STIM" Smart Tip will be used in this study.; Other Names: iovera
Active Comparator: Radiofrequency ablation; Subjects will receive RFA to nerves of the sacroiliac joint	Device: Radiofrequency ablation; Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With Pain Management	Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.	12 months
Pain Intensity	Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain. Subjects will evaluate how much pain they are currently experiencing and their average pain level over the past 24 hours.	0-12 Months
Functional disability	Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.	0-12 months
Concomitant medication use	Concomitant medication use will be collected per participant medication diary.	0-12 months
Success and failure rate of study interventions	Treatment success or failure will be determined at Day 180 (± 5 days) as described by Birkenmaier et al.: Full success of treatment is when pain is reduced to 50% or less of pre-treatment levels; Partial success of treatment is when pain is reduced between 51-69% of pre-treatment levels; Failure of treatment is when pain is reduced to 70% or greater of pre-treatment levels	Day 180
Shor-form 12 (SF-12)	Health-related quality of life will be measured by the short-form (SF) 12. The SF-12 is a self administered 12-item questionnaire that assesses an individual's physical and mental health status across eight domains. Total scores range form 0-100 with scores above 50 indicating better-than-average health-related quality of life, and scores below 50 indicating below-average health.	Screening, Day 90 (± 5 days), Day 180 (± 5 days), Day 270 (± 7 days), Day 360 (± 7 days)
Patients' Global Impression of Change	The Patients' Global Impression of Change (PGIC) is an 11-point self-report scale assessing overall changes in activity limitations, symptoms, emotions, and quality of life, ranging from 0 to 10, where higher values indicate worse outcomes.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lost work days	Lost work days related to low back pain will be self-reported to evaluate the impact of cryoneurolysis on the number of lost workdays compared to radiofrequency ablation.	0-12 months

Collaborators and Investigators

• Sponsor: Medical Pain Management Services, PLLC
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Martin Ferrillo, DO, The Albany & Saratoga Centers For Pain Management

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: low back pain; radiofrequency ablation; chronic low back pain; cryoneurolysis; sacroiliac joint pain; chronic sacroiliac joint pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia
• Other Study ID Numbers: CRS-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes