Chronic Low Back Pain (CLBP)ASTRALNCT07222462
A Superiority Trial of Radiofrequency Ablation for Low Back Pain
A study testing Lumbar radiofrequency ablation with conventional electrodes (LRFA-C), Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M) and Simulated lumbar radiofrequency ablation in people with Chronic Low Back Pain (CLBP), run by University of Washington at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Lumbar radiofrequency ablation with conventional electrodes (LRFA-C), Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M) and Simulated lumbar radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Feb 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory Musculoskeletal Institute
Atlanta, Georgia, 30329
Emory Orthopedics Clinical Research, 404-778-8099, isabelle.m.vernon@emory.edu
Mikhail Zhukalin, DO
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Nya Robinson, 216-445-1741, ROBINSN8@ccf.org
Alison Stout, DO
- Not yet recruiting
University of Utah Orthopaedic Center/PM&R
Salt Lake City, Utah, 84108
Research Study Coordinator, 801-213-8219, PMR.Research@hsc.utah.edu
Zachary McCormick, MD
About this study
Official title: ASTRAL: A Superiority Trial of Radiofrequency Ablation for Low Back Pain
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.
Read the detailed description
Low back pain is the #1 contributor to years lived with disability in the United States. Lumbar radiofrequency ablation (LRFA) is a minimally invasive procedure for chronic low back pain (CLBP) commonly used in the US, but the effectiveness of this procedure has yet to be fully explored, and a definitive, double-blind, multicenter RCT demonstrating a clinically relevant benefit of LRFA over a control procedure has yet to be conducted. LRFA-C involves placing a conventional radiofrequency electrode parallel to each targeted medial branch nerve, administering local anesthetic, and confirming placement with nerve stimulation as per standard clinical practice. LRFA-M follows the same processes as LRFA-C, albeit a multi-tined radiofrequency electrode will be used to create larger lesions, and the electrode will be positioned perpendicular to the medial branch nerve. The primary objectives of ASTRAL are to 1) compare the effectiveness of LRFA-C with a simulated LRFA control procedure for improving back-related functional limitations, and 2) compare the effectiveness of LRFA-M with a simulated LRFA control procedure for improving back-related functional limitations. The ASTRAL Study also aims to explore the difference in effectiveness, procedure duration, radiation dosage, and pain intensity between LRFA-C and LRFA-M.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Lumbar radiofrequency ablation with conventional electrodes (LRFA-C), Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M), Simulated lumbar radiofrequency ablation
- Keywords
- lumbar radiofrequency ablation (LRFA), corticosteroid injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)Procedure or surgery
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 or surgery
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 ablationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| LRFA-C | Active comparator | Lumbar radiofrequency ablation with conventional electrodes Receives: Procedure: Lumbar radiofrequency ablation with conventional electrodes (LRFA-C) |
| LRFA-M | Active comparator | Lumbar radiofrequency ablation with multi-tined electrodes Receives: Procedure: Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M) |
| Simulated LRFA | Sham comparator | Simulated lumbar radiofrequency ablation Receives: Procedure: Simulated lumbar radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back-related functional limitations
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability).
Measured: 3 months post-randomization
Secondary outcomes (15)
Back-related functional limitations
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability).
Measured: 1 month post-randomization
Back-related functional limitations
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability).
Measured: 6 months post-randomization
Back-related functional limitations
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability).
Measured: 12 months post-randomization
Procedure duration
Duration of the procedure in minutes
Measured: Day of intervention, after procedure
Radiation dose
Total radiation used during procedure
Measured: Day of intervention, after procedure
Participant pain during the procedure
Patient low back pain intensity experienced during the procedure will be assessed within 1 hour after the procedure, using the average of (a) patient rating of average pain intensity as experienced during the procedure and (b) patient rating of worst pain intensity as experienced during the procedure. The scale for each of these two items ranges from 0 (no pain) to 10 (worst pain imaginable).
Measured: Day of intervention, after procedure
Pain intensity
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: 3 months post-randomization
Pain intensity
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: 1 month post-randomization
Pain intensity
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: 6 months post-randomization
Pain intensity
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: 12 months post-randomization
Pain interference
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference).
Measured: 3 months post-randomization
Pain interference
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference).
Measured: 1 month post-randomization
Pain interference
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference).
Measured: 6 months post-randomization
Pain interference
Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference).
Measured: 12 months post-randomization
Time to receiving other procedural treatment for CLBP
From post-randomization, the number of days to receiving any other procedural treatment for CLBP
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start4 Feb 2026
- Primary completionMar 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Janna Friedly, University of Washington
- Investigators
- Pradeep Suri, MD, Principal investigator, University of WashingtonJanna Friedly, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222462
- Sponsor's protocol ID
- Pro00075903
- Other IDs
- U01AR084723
- Acronym
- ASTRAL
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data types for the full ASTRAL sample will include patient-reported outcome data; clinical and sociodemographic data entered by participants or by research staff at the clinical research center sites (CRCs) based on electronic health record (EHR) review; and adverse event monitoring data entered by participants or by research staff at the CRCs after EHR review. These de-identified, individual level data will be made available through a data repository consistent with NIH recommendations at the time of, for sharing to approved users via CSV files.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASTRAL: A Superiority Trial of Radiofrequency Ablation for Low Back Pain
- ClinicalTrials.gov ID
- NCT07222462
- Acronym / sponsor ID
- ASTRAL / Pro00075903
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- lumbar radiofrequency ablation (LRFA), corticosteroid injections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low back pain is the #1 contributor to years lived with disability in the United States. Lumbar radiofrequency ablation (LRFA) is a minimally invasive procedure for chronic low back pain (CLBP) commonly used in the US, but the effectiveness of this procedure has yet to be fully explored, and a definitive, double-blind, multicenter RCT demonstrating a clinically relevant benefit of LRFA over a control procedure has yet to be conducted. LRFA-C involves placing a conventional radiofrequency electrode parallel to each targeted medial branch nerve, administering local anesthetic, and confirming placement with nerve stimulation as per standard clinical practice. LRFA-M follows the same processes as LRFA-C, albeit a multi-tined radiofrequency electrode will be used to create larger lesions, and the electrode will be positioned perpendicular to the medial branch nerve. The primary objectives of ASTRAL are to 1) compare the effectiveness of LRFA-C with a simulated LRFA control procedure for improving back-related functional limitations, and 2) compare the effectiveness of LRFA-M with a simulated LRFA control procedure for improving back-related functional limitations. The ASTRAL Study also aims to explore the difference in effectiveness, procedure duration, radiation dosage, and pain intensity between LRFA-C and LRFA-M.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRFA-C | Active comparator | Procedure: Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)Lumbar radiofrequency ablation with conventional electrodes |
| LRFA-M | Active comparator | Procedure: Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M)Lumbar radiofrequency ablation with multi-tined electrodes |
| Simulated LRFA | Sham comparator | Procedure: Simulated lumbar radiofrequency ablationSimulated lumbar radiofrequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)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. | Procedure or surgery | LRFA-C |
| Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M)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. | Procedure or surgery | LRFA-M |
| Simulated lumbar radiofrequency ablationThe 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. | Procedure or surgery | Simulated LRFA |
Primary outcome
Back-related functional limitations
Time frame: 3 months post-randomization
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability).
15 secondary outcomes
Back-related functional limitations
Time frame: 1 month post-randomization
Back-related functional limitations
Time frame: 6 months post-randomization
Back-related functional limitations
Time frame: 12 months post-randomization
Procedure duration
Time frame: Day of intervention, after procedure
Radiation dose
Time frame: Day of intervention, after procedure
Participant pain during the procedure
Time frame: Day of intervention, after procedure
Pain intensity
Time frame: 3 months post-randomization
Pain intensity
Time frame: 1 month post-randomization
Pain intensity
Time frame: 6 months post-randomization
Pain intensity
Time frame: 12 months post-randomization
Pain interference
Time frame: 3 months post-randomization
Pain interference
Time frame: 1 month post-randomization
Pain interference
Time frame: 6 months post-randomization
Pain interference
Time frame: 12 months post-randomization
Time to receiving other procedural treatment for CLBP
Time frame: 12 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- ASTRAL Study general information websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data types for the full ASTRAL sample will include patient-reported outcome data; clinical and sociodemographic data entered by participants or by research staff at the clinical research center sites (CRCs) based on electronic health record (EHR) review; and adverse event monitoring data entered by participants or by research staff at the CRCs after EHR review. These de-identified, individual level data will be made available through a data repository consistent with NIH recommendations at the time of, for sharing to approved users via CSV files.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pradeep Suri, MD principal investigator
University of Washington
Janna Friedly, MD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar radiofrequency ablation with conventional electrodes (LRFA-C), Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M) and Simulated lumbar radiofrequency ablation in people with Chronic Low Back Pain (CLBP), run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Study Coordinator (206-210-4040, astralstudy@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back-related functional limitations (time frame: 3 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.