Can zapping nerves ease back pain? new trial aims to find out
NCT ID NCT07222462
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
The ASTRAL study is testing whether radiofrequency ablation, a procedure that uses heat to quiet certain nerves, can reduce pain and improve function in people with chronic low back pain. Researchers will compare two types of ablation to a fake (sham) procedure in 300 adults. The main goal is to see if the real treatments lead to less disability over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiofrequency ablation
- What this could lead to
- If it works, this could provide a non-surgical option for people with chronic low back pain who haven't found relief from other treatments.
- What could go wrong
- This is a single trial with a sham control, so results may not apply to everyone. The procedure carries risks like nerve damage or infection, and the benefit may be small or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * 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: * CLBP attributed primarily to specific spine-related conditions (radiculopathy, lumbar spinal stenosis, spinal instability), 'red flag' conditions (infection / malignancy / fracture), and/or inflammatory arthritis (RA, SpA, etc.) * 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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Emory Musculoskeletal Institute
RECRUITINGAtlanta, Georgia, 30329, United States
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University of Utah Orthopaedic Center/PM&R
NOT_YET_RECRUITINGSalt Lake City, Utah, 84108, United States
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