Cryoneurolysis for Facet Mediated Chronic Low Back Pain

A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Facet Joint Pain
• Intervention / Treatment: Device: iovera system; Device: Radiofrequency ablation

Detailed Description

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.

This study is designed to determine if a full efficacy RCT can be successfully conducted using the procedures and protocols described in the current pilot study protocol, or if protocol modifications are necessary before moving forward with a full efficacy RCT. 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 the full efficacy RCT.

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

• Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine
• Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine

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

Contacts and Locations

Study Locations

• United States
  • New York
    • Saratoga Springs, New York, United States, 12866
      • The Albany & Saratoga Centers For Pain Management

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female volunteers, at least 18 years of age at screening
2. Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP)
3. Low back pain is chronic (i.e., > 3 months' duration)
4. Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment at screening
5. 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)
6. Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics),
7. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

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 lumbar spinal fusion surgery
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 devices, 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. 3.5-inch needle cannot be used in the low back region because of habitus
8. Severe chronic pain disorder that in the opinion of the investigator may impact postsurgical outcomes

9. Presence of any of the following:

   1. Spinal neurostimulator
   2. Intrathecal analgesic drug pump

10. Current manifestation of poorly controlled mental illness that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:

    1. Mood disorder (e.g., major depression, bipolar)
    2. Psychotic disorder (e.g., schizophrenia)
11. Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies)
12. Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment

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 treatment 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 treatment 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 medial branch nerves of the lumbar spine	Device: iovera system; 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.; Other Names: iovera
Active Comparator: Radiofrequency ablation; Subjects will receive RFA to the medial branch nerves of the lumbar spine	Device: Radiofrequency ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity as measured by 11-point Numeric Rating Scale (NRs)	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 worst and average level of pain over the past 24 hours.	0-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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
Change in Patients' Global Impression of Change	The Patients' Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall change in activity limitations, symptoms, emotions, and quality of life ranging from 1) no change 2) hardly any change 3) no noticeable change 4) change has not made any real difference 5) a slight but noticeable change 6) a definite improvement 7) considerable improvement. The scale also assesses degree of change since beginning care (0=much better, 10=much worse).	0-12 months
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.	0-12 months

Collaborators and Investigators

• Sponsor: Medical Pain Management Services, PLLC
• Collaborators: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2022
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Back Pain; Low Back Pain
• Other Study ID Numbers: CRS-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Contact PI

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