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New treatment option for Chronic Low Back Pain (CLBP)
Official title A Superiority Trial of Radiofrequency Ablation for Low Back Pain
ClinicalTrials.gov ID: NCT07222462
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)
You likely can't join if
- CLBP attributed primarily to specific spine-related conditions (radiculopathy, lumbar spinal stenosis, spinal instability), 'red flag' conditions...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Cleveland, Ohio, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Cleveland, Ohio, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.