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Chronic Low-back PainLumbar CvSNCT04803149

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

A study testing Cooled Radiofrequency and Conventional Radiofrequency in people with Chronic Low-back Pain, run by Avanos Medical at 10 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Cooled Radiofrequency and Conventional Radiofrequency
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
10 sitesUnited States
Study dates
23 Feb 2021to Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved).
  • Pending or active compensation claim, litigation, or disability remuneration (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
  • Pregnant, nursing or intent of becoming pregnant during the study period
  • Chronic pain associated with significant psychosocial dysfunction.
  • Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator.
  • Allergies to any of the medications to be used during the procedures
  • History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable.
  • Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
  • Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse.
  • Current prescribed opioid medications greater than 50 morphine equivalent daily opioid dose.
  • Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.).
  • Subject currently implanted with pacemaker, stimulator or defibrillator.
  • Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent.
  • Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Millennium Pain Center

    Bloomington, Illinois, 61704

  • The Spine and Nerve Centers of St. Francis Hosptial

    Charleston, West Virginia, 25301

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • University of Utah

    Salt Lake City, Utah, 84108

  • Pain Diagnostics and Interventional Care

    Sewickley, Pennsylvania, 15143

  • Premier Pain Centers

    Shrewsbury, New Jersey, 07702

  • University Orthopedics Center

    State College, Pennsylvania, 16801

  • International Spine & Pain Performance Center

    Washington D.C., District of Columbia, 20006

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cooled Radiofrequency, Conventional Radiofrequency
Keywords
Pain Management, Lumbar facet syndrome, Radiofrequency Ablation, Low Back, Medial Branch Nerves
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cooled RadiofrequencyDevice

    Also called Coolief

    Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

  • Conventional RadiofrequencyDevice

    Also called Standard Radiofrequency

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

Study groups in NCT04803149
Study groupRoleWhat they receive
Cooled RadiofrequencyExperimentalCooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Receives: Device: Cooled Radiofrequency
Conventional RadiofrequencyActive comparatorConventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Receives: Device: Conventional Radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Proportion of subjects experiencing adverse events through 6-months

    Measured: 6 months

Secondary outcomes (5)

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start23 Feb 2021
  3. Primary completionJan 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04803149
Sponsor's protocol ID
105-20-0006
Acronym
Lumbar CvS
Status last verified
Jun 2022
First submitted
12 Mar 2021
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Provenzano DA, Li S, Deer TA, Kapural L, Khalouf FK, Vetri F, Zora KM, Guirguis MN, McCormick ZL. Prospective, non-inferiority, multicenter, randomized, single-blind clinical trial comparing cooled radiofrequency ablation to standard radiofrequency ablation to manage chronic facetogenic lumbar back pain. Reg Anesth Pain Med. 2026 Mar 13:rapm-2025-107299. doi: 10.1136/rapm-2025-107299. Online ahead of print.

    PubMed 41825940

Questions about this trial

What is this clinical trial studying?

A study testing Cooled Radiofrequency and Conventional Radiofrequency in people with Chronic Low-back Pain, run by Avanos Medical at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04803149, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.

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