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Trial record 1 of 1 for:    radiofrequency | low back pain | Sewickley, Pennsylvania, U.S.
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Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain (Lumbar CvS)

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ClinicalTrials.gov Identifier: NCT04803149
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Avanos Medical

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Device: Cooled Radiofrequency Device: Conventional Radiofrequency Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The study is a participant-blinded trial and deliberate action, utilizing a physical barrier, will be taken to ensure the blind remains intact.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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 Name: Standard Radiofrequency




Primary Outcome Measures :
  1. The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months [ Time Frame: 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.

  2. Proportion of subjects experiencing adverse events through 6-months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit [ Time Frame: 6 months ]
    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

  2. The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit [ Time Frame: 6 months ]
    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

  3. The measured Global Perceived Effect scale at the 6-month visit [ Time Frame: 6 months ]
    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.

  4. The mean change in EQ-5D-5L score from baseline to the 6-month visit [ Time Frame: 6 months ]
    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.

  5. The proportion of subjects requiring additional intervention for their back pain during the 6-month period [ Time Frame: 6 months ]

Other Outcome Measures:
  1. The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 12 Months [ Time Frame: 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.

  2. Proportion of subjects experiencing adverse events through 12 months [ Time Frame: 12 months ]
  3. The mean change in SF-36 Physical Functioning (PF) score from baseline to the 12-month visit [ Time Frame: 12 months ]
    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

  4. The mean change in Oswestry Disability Index (ODI) score from baseline to the 12-month visit [ Time Frame: 12 months ]
    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

  5. The measured Global Perceived Effect scale at the 12-month visit [ Time Frame: 12 months ]
    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. The mean change in EQ-5D-5L score from baseline to the 12-month visit [ Time Frame: 12 months ]
    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.

  7. The proportion of subjects requiring additional intervention for their back pain during the 12-month period [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803149


Contacts
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Contact: William Keck 470-448-5509 William.Keck@avanos.com
Contact: David Curd 314-480-2244 David.Curd@avanos.com

Locations
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United States, Illinois
Millennium Pain Center Recruiting
Bloomington, Illinois, United States, 61704
Contact: Eliezer Soto    309-662-4321      
United States, Louisiana
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Maged Guirguis    504-842-5300      
United States, New Jersey
Premier Pain Centers Recruiting
Shrewsbury, New Jersey, United States, 07702
Contact: Sean Li, MD    732-930-2423      
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Leonardo Kapural, MD    336-714-8381      
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Fred Khalouf, DO    814-942-1166 ext 4235    fkhalouf@uoc.com   
Pain Diagnostics and Interventional Care Recruiting
Sewickley, Pennsylvania, United States, 15143
Contact: David Provenzano    412-221-7640    davidprovenzano@hotmail.com   
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Keith Zora, DO    814-272-3751    kzora@uoc.com   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Zachary McCormick    801-587-5458    Zachary.McCormick@hsc.utah.edu   
United States, West Virginia
The Spine and Nerve Centers of St. Francis Hosptial Recruiting
Charleston, West Virginia, United States, 25301
Contact: Timothy Deer    304-347-6120      
Sponsors and Collaborators
Avanos Medical
Investigators
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Principal Investigator: David Provenzano Pain Diagnostics and Interventional Care
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Responsible Party: Avanos Medical
ClinicalTrials.gov Identifier: NCT04803149    
Other Study ID Numbers: 105-20-0006
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021

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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
Keywords provided by Avanos Medical:
Pain Management
Lumbar facet syndrome
Radiofrequency Ablation
Low Back
Medial Branch Nerves
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations