Actively Recruiting
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
182 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
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.
CONDITIONS
Official 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 as pain between the lower rib cage and the horizontal gluteal fold
- Low back pain intensity rating of 4 or higher before lumbar radiofrequency ablation
- Has received conservative treatments for low back pain such as physical therapy, exercise, spinal manipulation, massage, or acupuncture
- Candidate for unilateral lumbar radiofrequency ablation at up to 3 spinal levels or bilateral up to 2 spinal levels (L1-S1 joints)
- Positive response (80% or greater improvement) to two sets of anesthetic-only medial branch blocks
- Able to read, speak, and understand English for informed consent
- Willing to comply with study procedures and available for the full study duration with signed informed consent
You will not qualify if you...
- Chronic low back pain mainly caused by specific spine conditions like radiculopathy, spinal stenosis, spinal instability, infection, malignancy, fracture, or inflammatory arthritis
- Prior lumbar radiofrequency ablation treatment
- Corticosteroid injections in lumbar facet joints or medial branch nerves within the past 6 months
- Spinal surgery involving treated levels in the past 2 years
- Any lumbar fusion involving the spinal levels targeted by the study
- Severe lumbar central canal stenosis seen on MRI
- Prior formal diagnosis of fibromyalgia by a rheumatologist
- Unstable psychiatric or terminal medical conditions limiting participation
- Pregnancy or prisoner status
- Prior formal diagnosis of cognitive impairment confirmed by neuropsychologist or neurologist
- Allergy or contraindication to local anesthetic, corticosteroid, or any part of the lumbar radiofrequency ablation procedure
- Unable to reach medial branch block targets with an 11.9 cm needle
- Planned major life events in next 4 months that could interfere with participation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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