A Superiority Trial of Radiofrequency Ablation for Low Back Pain

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Washington
Study ID
NCT07222462
Status
Recruiting
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Conditions

  • Chronic Low Back Pain (CLBP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lumbar radiofrequency ablation with conventional electrodes (LRFA-C) — PROCEDURE
    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) — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

The purpose of the ASTRAL Study is to evaluate the effectiveness of LRFA (Lumbar radiofrequency ablation) against a control procedure. The ASTRAL Study will enroll individuals with chronic low back pain (CLBP) and randomly assign them to one of three groups: lumbar radiofrequency ablation using conventional electrodes placed parallel to the medial branch nerves (LRFA-C), lumbar radiofrequency ablation using multi-tined electrodes placed perpendicular to the medial branch nerves (LRFA-M), or a simulated radiofrequency ablation procedure.

Key Dates

Start date
Feb 4, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: LRFA-C
    Lumbar radiofrequency ablation with conventional electrodes
  • Active Comparator: LRFA-M
    Lumbar radiofrequency ablation with multi-tined electrodes
  • Sham Comparator: Simulated LRFA
    Simulated lumbar radiofrequency ablation

Primary Outcome Measure

Back-related functional limitations [ Time Frame: 3 months post-randomization ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Musculoskeletal InstituteAtlantaGeorgia30329
Emory Orthopedics Clinical Research
[email protected]
404-778-8099
Mikhail Zhukalin, DO (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Nya Robinson
[email protected]
216-445-1741
Alison Stout, DO (PRINCIPAL_INVESTIGATOR)
University of Utah Orthopaedic Center/PM&RSalt Lake CityUtah84108
Research Study Coordinator
[email protected]
801-213-8219
Zachary McCormick, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory Musculoskeletal Institute· Atlanta, GACleveland Clinic· Cleveland, OHUniversity of Utah Orthopaedic Center/PM&R· Salt Lake City, UT

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