A Superiority Trial of Radiofrequency Ablation for Low Back Pain
NCT ID: NCT07222462
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2026-01-31
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LRFA-C
Lumbar radiofrequency ablation with conventional electrodes
Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)
LRFA-C positions a conventional thermal radiofrequency electrode at each medial branch nerve to be ablated and administers local anesthetic to the nerve. Parallel placement of the electrode will be achieved. Once the electrode is in correct position and nerve stimulation testing done, a radiofrequency lesion is generated, achieving a temperature 80°C-90°C, lasting 90-120 seconds. If a 16-gauge or larger electrode is used, no second lesion needs to be made. If an 18-gauge electrode is used, the electrode will be repositioned slightly by withdrawing or repositioning parallel to the 1st ablation site, or by rotating the electrode, and a 2nd lesion made. Local corticosteroid injection is then performed at the ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
LRFA-M
Lumbar radiofrequency ablation with multi-tined electrodes
Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M)
LRFA-M positions a multi-tined thermal radiofrequency electrode at each medial branch nerve to be ablated and administers local anesthetic to the nerve. However, the multi-tined thermal radiofrequency electrode is thought to achieve larger lesions and thus does not require parallel electrode placement; the LRFA-M electrode will be placed perpendicular to the medial branch nerve. All subsequent processes are the same as for LRFA-C. This includes local corticosteroid injection at each ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
Simulated LRFA
Simulated lumbar radiofrequency ablation
Simulated lumbar radiofrequency ablation
The simulated LRFA control procedure will be performed in an identical fashion to LRFA-M, except 1) after electrode positioning, a neurodestructive lesion will not be made; and 2) a pre-recorded audio recording of the procedure will be played (out of view of the patient, immediately adjacent to the RFA machine) in order to simulate the beeping and other sounds of the machine and to ensure the appropriate length of the simulated procedure. The electrode will remain in place for the 90-120 seconds that lesioning would normally take, but without heat application. The electrode will then be repositioned to simulate a second lesion, also of duration 90-120 seconds. Local corticosteroid injection is then performed at the ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
Interventions
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Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)
LRFA-C positions a conventional thermal radiofrequency electrode at each medial branch nerve to be ablated and administers local anesthetic to the nerve. Parallel placement of the electrode will be achieved. Once the electrode is in correct position and nerve stimulation testing done, a radiofrequency lesion is generated, achieving a temperature 80°C-90°C, lasting 90-120 seconds. If a 16-gauge or larger electrode is used, no second lesion needs to be made. If an 18-gauge electrode is used, the electrode will be repositioned slightly by withdrawing or repositioning parallel to the 1st ablation site, or by rotating the electrode, and a 2nd lesion made. Local corticosteroid injection is then performed at the ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M)
LRFA-M positions a multi-tined thermal radiofrequency electrode at each medial branch nerve to be ablated and administers local anesthetic to the nerve. However, the multi-tined thermal radiofrequency electrode is thought to achieve larger lesions and thus does not require parallel electrode placement; the LRFA-M electrode will be placed perpendicular to the medial branch nerve. All subsequent processes are the same as for LRFA-C. This includes local corticosteroid injection at each ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
Simulated lumbar radiofrequency ablation
The simulated LRFA control procedure will be performed in an identical fashion to LRFA-M, except 1) after electrode positioning, a neurodestructive lesion will not be made; and 2) a pre-recorded audio recording of the procedure will be played (out of view of the patient, immediately adjacent to the RFA machine) in order to simulate the beeping and other sounds of the machine and to ensure the appropriate length of the simulated procedure. The electrode will remain in place for the 90-120 seconds that lesioning would normally take, but without heat application. The electrode will then be repositioned to simulate a second lesion, also of duration 90-120 seconds. Local corticosteroid injection is then performed at the ablation site at a total corticosteroid equivalent of 80mg triamcinolone, divided equally among the medial branches targeted; this dose can be reduced as needed according to the medical status of each patient. This process is applied for each medial branch nerve targeted.
Eligibility Criteria
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Inclusion Criteria
* CLBP of duration ≥ 3 months. Low back pain is defined as occurring between the lower posterior margin of the rib cage and the horizontal gluteal fold.
* Low back pain intensity numerical rating scale (NRS) ≥ 4 with one of the following prior to LRFA: 1) Current low back pain intensity, 2) Average pain over past 7 days, OR 3) Pain intensity without specification of recall period
* Has had conservative treatments for CLBP (physical therapy, exercise therapy, spinal manipulation, massage, acupuncture, etc.)
* Candidate for unilateral LRFA (L1-S1 joints; ≤3 levels); or bilateral LRFA (L1-S1 joints; ≤2 levels)
* 'Positive responses' (≥80% improvement of CLBP pain intensity) to 2 sets of anesthetic-only MBBs (≤0.5cc of local anesthetic)
* Able to read, speak, and understand English sufficient for informed consent purposes
* Stated willingness to comply with all study processes and availability for the duration of the study, and provision of a signed and dated informed consent form
Exclusion Criteria
* Prior LRFA
* Prior lumbar facet joint (intra-articular or medial branch nerve) corticosteroid injections (past 6 months)
* Surgery involving one or more of spinal levels where LRFA is to be performed, in the past 2 years
* Lumbar fusion involving the spinal levels where LRFA is considered, at any time
* Prior known severe lumbar central canal stenosis on MRI as defined by Lee (2011): obliteration of the cerebrospinal fluid (CSF), and marked compression of dural sac, and none of the cauda equina can be visually separated from each other. No new MRIs would be done specifically as part of the study processes.
* Prior formal diagnosis of fibromyalgia by a rheumatologist (diagnosis by primary care physician or pain medicine specialist is not sufficient)
* Unstable psychiatric or terminal medical conditions that would limit study participation and the likelihood of follow-up for 12 months post-randomization
* Pregnancy, being a prisoner, or having a prior formal diagnosis of cognitive impairment by a neuropsychologist or neurologist, confirmed by health record documentation
* Participant report of prior formal diagnosis of cognitive impairment by a neuropsychologist or neurologist can be obtained, but participant-reported cognitive impairment by a neuropsychologist or neurologist must be confirmed via health record documentation. No new evaluations for cognitive impairment would be done specifically as part of the study processes.
* Contraindication to local anesthetic, corticosteroid, or any aspects of LRFA
* Cannot reach MBB targets with 11.9cm needle
* Major planned life events over the next 4 months that might interfere with study participation (e.g., major abdominal or chest surgery or extended vacation)
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Washington
OTHER
Responsible Party
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Janna Friedly
Multiple Principal Investigator
Principal Investigators
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Pradeep Suri, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Janna Friedly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Emory Musculoskeletal Institute
Atlanta, Georgia, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Utah Orthopaedic Center/PM&R
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Emory Orthopedics Clinical Research
Role: primary
Nya Robinson
Role: primary
Research Study Coordinator
Role: primary
Related Links
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ASTRAL Study general information website
Other Identifiers
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Pro00075903
Identifier Type: -
Identifier Source: org_study_id