Actively Recruiting
ASTRAL: A Superiority Trial of Radiofrequency Ablation for Low Back Pain
Led by University of Washington · Updated on 2026-02-09
300
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness of lumbar radiofrequency ablation (LRFA) for people with chronic low back pain (CLBP). The study compares two types of LRFA procedures—using conventional electrodes placed parallel to the medial branch nerves (LRFA-C) and multi-tined electrodes placed perpendicular to those nerves (LRFA-M)—against a simulated procedure that mimics the treatment without applying heat. This trial addresses the need for clear evidence on whether LRFA provides meaningful benefits for improving back-related function and pain. Participants will be randomly assigned to one of three groups: LRFA-C, LRFA-M, or a simulated LRFA control. Both LRFA procedures involve targeting medial branch nerves with electrodes, administering local anesthetic, generating radiofrequency lesions at specific temperatures and durations, and applying corticosteroid injections at each site. The simulated procedure follows the same steps but does not generate lesions; instead, it uses recorded sounds to mimic the treatment duration. The study measures differences in procedure time, radiation exposure, and pain during the intervention between the two LRFA methods. During the study, participants will be followed and evaluated at multiple points, including 1, 3, 6, and 12 months after randomization. Researchers will assess back-related functional limitations and pain intensity, as well as pain interference with daily activities. They will also monitor procedure duration, radiation dose, and any need for further procedural treatment for CLBP. These assessments involve questionnaires and clinical evaluations to understand the impact of each treatment method over time.
CONDITIONS
Brief Title
A Superiority Trial of Radiofrequency Ablation for Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic low back pain lasting 3 months or more, defined between lower rib cage and gluteal fold
- Low back pain intensity rating of 4 or higher by current pain, average past 7 days, or unspecified recall
- Prior conservative treatments such as physical therapy, exercise, spinal manipulation, massage, or acupuncture
- Candidate for unilateral LRFA on up to 3 spinal levels or bilateral LRFA on up to 2 spinal levels
- Positive pain improvement (80% or more) to two sets of anesthetic-only medial branch blocks
- Ability to read, speak, and understand English
- Willingness to comply with study procedures and availability for study duration
- Signed and dated informed consent form
You will not qualify if you...
- Low back pain caused primarily by specific spine conditions like radiculopathy, spinal stenosis, instability, infection, malignancy, fracture, or inflammatory arthritis
- Prior lumbar radiofrequency ablation
- Lumbar facet joint corticosteroid injections within past 6 months
- Spinal surgery at targeted levels within past 2 years
- Any lumbar fusion at targeted spinal levels
- Known severe lumbar central canal stenosis on prior MRI
- Formal fibromyalgia diagnosis by a rheumatologist
- Unstable psychiatric or terminal medical conditions limiting participation
- Pregnancy or prisoner status
- Formal diagnosis of cognitive impairment confirmed by neuropsychologist or neurologist
- Contraindications to local anesthetic, corticosteroid, or LRFA procedure
- Unable to reach medial branch block targets with needle length
- Major planned life events in next 4 months that could interfere with participation (e.g., major surgery, extended vacation)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive one of three procedures: lumbar radiofrequency ablation with conventional electrodes (LRFA-C), lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M), or a simulated lumbar radiofrequency ablation control procedure. Each procedure involves electrode placement, local anesthetic administration, and corticosteroid injection at the ablation site.
1 treatment visit (in-person)
Duration - 12 months post-treatment
Participants are monitored through multiple follow-up visits to assess back-related functional limitations, pain intensity, pain interference, and other outcomes over time after the procedure.
4 follow-up visits at 1, 3, 6, and 12 months post-randomization
Trial Site Locations
Total: 3 locations
1
Emory Musculoskeletal Institute
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
University of Utah Orthopaedic Center/PM&R
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
Research Team
R
Research Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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