Cryoneurolysis for Facet Mediated Chronic Low Back Pain

NCT06016127 | Completed Results FDA Device

• 1 other identifier: CRS-107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.

Conditions

Low Back Pain; Facet Joint Pain

Keywords

low back pain

Outcome Measures

Primary Outcomes (1)

• Safety 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 (1)

• Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up

  12 months

Other Outcomes (3)

• Functional Disability Index at 12 Month Follow up

  0-12 months

• Patients' Global Impression of Change at 12 Month Follow up

  12 months

• Satisfaction With Pain Management

  12 months

Study Arms (2)

Cryoneurolysis

ACTIVE COMPARATOR

Subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine

Device: iovera system

Radiofrequency ablation

ACTIVE COMPARATOR

Subjects will receive RFA to the medial branch nerves of the lumbar spine

Device: Radiofrequency ablation

Interventions

iovera system 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 "190" Smart Tip will be used in this study.

Also known as: iovera

Cryoneurolysis

Radiofrequency ablation DEVICE

The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.

Radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

• Male or female volunteers, at least 18 years of age at screening
• Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP)
• Low back pain is chronic (i.e., \> 3 months' duration)
• Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment at screening
• Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used or history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months prior to enrollment)
• Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics),
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

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 lumbar spinal fusion surgery
• 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 devices, including any of the following:
• Cryoglobulinemia
• Paroxysmal cold hemoglobinuria

Sponsors & Collaborators

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

Study Sites (1)

The Albany & Saratoga Centers For Pain Management

Saratoga Springs, New York, 12866, United States

Location

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

Results Point of Contact

• Title: Kasandra Cliff
• Organization: Albany Saratoga Centers for Pain Management

khopkins@northwayspc.com

518-371-6772

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• 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: August 21, 2023
• First Posted: August 29, 2023
• Study Start: June 18, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)