Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain (Lumbar CvS)

A Prospective, Multi-center, Randomized, Single-Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Medial Branch Nerves in the Management of Chronic Facetogenic Low Back Pain

This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF* Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Device: Cooled Radiofrequency; Device: Conventional Radiofrequency

Detailed Description

This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with chronic axial low back pain that originates in the lumbar facet joints undergoing a procedure to create a radiofrequency lesion in the medial branch nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 188 participants from approximately 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-treatment, with the primary endpoint being completed at month 6. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • International Spine & Pain Performance Center
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Millennium Pain Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Baptist Medical Center
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Centers
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center
    • Sewickley, Pennsylvania, United States, 15143
      • Pain Diagnostics and Interventional Care
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine and Nerve Centers of St. Francis Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 21 years
2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
3. Subjects who have chronic axial (non-radicular) low back pain (at least 3 months) attributed to bilateral L4/L5, L5/S1 lumbar facet joint arthropathy based on clinical evaluation (paraspinal tenderness in the absence of signs and symptoms suggestive of focal neurological deficits) despite conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs]).
4. Positive response to dual diagnostic medial branch blocks (defined as a decrease in numeric pain scores of at least 80% for a min of 3 hours for bupivacaine and minimum of 2 hours for lidocaine) using 0.5mL or less of 0.5% bupivacaine and 2% lidocaine, on respective encounters on separate days, at each of the appropriate medial branches.
5. Usual/Average Pain ≥ 6 on an 11-point NRS scale.
6. Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the study without approval of the investigator.
7. Agree to see one physician (study physician) for back pain during the study period.
8. Subjects of child bearing potential must be willing to utilize double barrier contraceptive method for duration of participation.
9. Willingness to comply with the requirements of this protocol for the full duration of the study.

Exclusion Criteria:

1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause pain.
2. Focal neurologic signs or symptoms.
3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at an affected joint or adjacent level, or significant lumbar scoliosis (sagittal vertical axis angle >5 degrees or Cobb Angle >10 degrees).
4. Suspected mechanical instability based on flexion/extension and/or films at the proposed treatment levels
5. History of prior lumbar fusion or previous lumbar back surgery at the intended treatment levels.
6. Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy.
7. Radiologic evidence of a symptomatic herniated disc or nerve root impingement.
8. Symptomatic moderate or severe foramina or central canal stenosis demonstrating radicular symptoms or neurogenic claudication.
9. Evidence of neuropathic pain affecting the lower back.
10. Intra-articular steroid injection at target levels within 90 days from randomization.
11. Platelet rich plasma (PRP) or stem cells at target levels within 180 days from randomization.
12. Prior lumbar radiofrequency neurotomy of the L3/L4, L4/L5 medial branches and/or L5/S1dorsal ramus.
13. Body mass index (BMI) > 40 kg/m2
14. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns.
15. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved).
16. Pending or active compensation claim, litigation, or disability remuneration (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
17. Pregnant, nursing or intent of becoming pregnant during the study period
18. Chronic pain associated with significant psychosocial dysfunction.
19. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator.
20. Allergies to any of the medications to be used during the procedures
21. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable.
22. Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
23. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse.
24. Current prescribed opioid medications greater than 50 morphine equivalent daily opioid dose.
25. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.).
26. Subject currently implanted with pacemaker, stimulator or defibrillator.
27. Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent.
28. Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cooled Radiofrequency; Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain	Device: Cooled Radiofrequency; Delivery of energy to ablate sensory nerves via cooled radiofrequency probe; Other Names: Coolief
Active Comparator: Conventional Radiofrequency; Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain	Device: Conventional Radiofrequency; Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe; Other Names: Standard Radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months	The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals "worst pain". There are no sub-scales.	6 months
Proportion of subjects experiencing adverse events through 6-months		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit	Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group	6 months
The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit	ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group	6 months
The measured Global Perceived Effect scale at the 6-month visit	The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales.	6 months
The mean change in EQ-5D-5L score from baseline to the 6-month visit	This outcome instrument is composed two components. The first component consists of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. The second component, EQ-Visual Analog Scale (VAS), has a score range of 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.	6 months
The proportion of subjects requiring additional intervention for their back pain during the 6-month period		6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 12 Months	The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals "worst pain". There are no sub-scales.	12 months
Proportion of subjects experiencing adverse events through 12 months		12 months
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 12-month visit	Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group	12 months
The mean change in Oswestry Disability Index (ODI) score from baseline to the 12-month visit	ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group	12 months
The measured Global Perceived Effect scale at the 12-month visit	The Global Perceived Effect is a 7-point scale: 1 point = "worst ever", 2 points = "much worse", 3 points = "worse", 4 points = "not improved but not worse", 5 points = "improved", 6 points = "much improved", 7 points = "best ever". There are no sub-scales.	12 months
The mean change in EQ-5D-5L score from baseline to the 12-month visit	This outcome instrument is composed two components. The first component consists of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with "1" indicating the best study subject condition and "5" indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. The second component, EQ-Visual Analog Scale (VAS), has a score range of 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.	12 months
The proportion of subjects requiring additional intervention for their back pain during the 12-month period		12 months

Collaborators and Investigators

• Sponsor: Avanos Medical
• Investigators: Principal Investigator: David Provenzano, Pain Diagnostics and Interventional Care

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Pain Management; Low Back; Lumbar facet syndrome; Medial Branch Nerves
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 105-20-0006

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