Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07214844

A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Led by Montefiore Medical Center · Updated on 2026-04-23

110

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

P

Pacira Pharmaceuticals, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.

CONDITIONS

Official Title

A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old at screening
  • Primary axial low-back pain suggesting bilateral facet joint involvement confirmed by provocative tests
  • Chronic low back pain lasting 3 months or more
  • Moderate to severe low back pain with a numeric rating score between 5 and 9 at screening
  • Functional impairment with at least 30% disability on the Oswestry Disability Index at screening
  • Two successful diagnostic medial branch blocks with local anesthetic only showing at least 80% pain relief
  • Failed at least three months of conservative non-operative therapy such as physical therapy, chiropractic care, or analgesics
  • Able to consent, follow study visits, and complete assessments
Not Eligible

You will not qualify if you...

  • Active workers' compensation, personal injury, disability insurance, or litigation related to the spine
  • Serious spinal disorders including suspected cauda equina syndrome, infection, tumor, fracture, systemic inflammatory spondyloarthropathy, lumbar radiculopathy, neurogenic claudication, or prior lumbar fusion at treatment levels
  • Comorbidities affecting participation such as lumbar radiculopathy or neuropathic pain disorder
  • Currently pregnant, nursing, or planning pregnancy during the study
  • Known contraindications to study device including cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, infected wounds near treatment site, or coagulopathy
  • Severe chronic pain disorder impacting outcomes
  • Presence of spinal neurostimulator, intrathecal analgesic pump, or cardiac implantable device
  • Poorly controlled mental illness or catastrophizing impacting outcomes, including mood disorders with PHQ-9 score 12 or higher, psychotic disorders, or PCS score over 30
  • Spine interventions within 30 days prior to block administration
  • Radiofrequency ablation in low back within 6 months prior to enrollment
  • Pain relief from diagnostic medial branch blocks lasting longer than local anesthetic duration
  • History or suspicion of alcohol or illicit drug abuse
  • Opioid dependence exceeding 40 mg per day in past 30 days
  • Not medically fit or cleared for surgery due to COVID-19 or other serious illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Multidisciplinary Pain Program

The Bronx, New York, United States, 10461

Actively Recruiting

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Research Team

K

Karina Gritsenko, MD

CONTACT

R

Rafi Khandaker, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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