Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain

NCT04803149 | Unknown FDA Device

• 1 other identifier: 105-20-0006
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

Pain Management; Lumbar facet syndrome; Radiofrequency Ablation; Low Back; Medial Branch Nerves

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit

  6 months

• The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit

  6 months

• The measured Global Perceived Effect scale at the 6-month visit

  6 months

• The mean change in EQ-5D-5L score from baseline to the 6-month visit

  6 months

• The proportion of subjects requiring additional intervention for their back pain during the 6-month period

  6 months

Other Outcomes (7)

• The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 12 Months

  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

  12 months

Study Arms (2)

Cooled Radiofrequency

EXPERIMENTAL

Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Device: Cooled Radiofrequency

Conventional Radiofrequency

ACTIVE COMPARATOR

Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Device: Conventional Radiofrequency

Interventions

Cooled Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Also known as: Coolief

Cooled Radiofrequency

Conventional Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe

Also known as: Standard Radiofrequency

Conventional Radiofrequency

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
• 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 \[NSAIDs\]).
• 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.
• Usual/Average Pain ≥ 6 on an 11-point NRS scale.
• 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.
• Agree to see one physician (study physician) for back pain during the study period.
• Subjects of child bearing potential must be willing to utilize double barrier contraceptive method for duration of participation.
• Willingness to comply with the requirements of this protocol for the full duration of the study.

You may not qualify if:

• Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause pain.
• Focal neurologic signs or symptoms.
• 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).
• Suspected mechanical instability based on flexion/extension and/or films at the proposed treatment levels
• History of prior lumbar fusion or previous lumbar back surgery at the intended treatment levels.
• Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy.
• Radiologic evidence of a symptomatic herniated disc or nerve root impingement.
• Symptomatic moderate or severe foramina or central canal stenosis demonstrating radicular symptoms or neurogenic claudication.
• Evidence of neuropathic pain affecting the lower back.
• Intra-articular steroid injection at target levels within 90 days from randomization.
• Platelet rich plasma (PRP) or stem cells at target levels within 180 days from randomization.
• Prior lumbar radiofrequency neurotomy of the L3/L4, L4/L5 medial branches and/or L5/S1dorsal ramus.
• Body mass index (BMI) \> 40 kg/m2
• 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.
• Pending or active compensation claim, litigation, or disability remuneration (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).

Sponsors & Collaborators

• Avanos Medical: lead

Study Sites (10)

International Spine & Pain Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61704, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

The Spine and Nerve Centers of St. Francis Hosptial

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Provenzano

  Pain Diagnostics and Interventional Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is a participant-blinded trial and deliberate action, utilizing a physical barrier, will be taken to ensure the blind remains intact.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: February 23, 2021
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (10)