A Superiority Trial of Radiofrequency Ablation for Low Back Pain (ASTRAL)

February 5, 2026 updated by: Janna Friedly, University of Washington

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory Musculoskeletal Institute
        • Principal Investigator:
          • Mikhail Zhukalin, DO
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Alison Stout, DO
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Not yet recruiting
        • University of Utah Orthopaedic Center/PM&R
        • Principal Investigator:
          • Zachary McCormick, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: LRFA-C
Lumbar radiofrequency ablation with conventional electrodes
Procedure: 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.
Active Comparator: LRFA-M
Lumbar radiofrequency ablation with multi-tined electrodes
Procedure: 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.
Sham Comparator: Simulated LRFA
Simulated lumbar radiofrequency ablation
Procedure: Simulated lumbar radiofrequency ablation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
3 months post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Back-related functional limitations
Time Frame: 1 month 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).
1 month post-randomization
Back-related functional limitations
Time Frame: 6 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).
6 months post-randomization
Back-related functional limitations
Time Frame: 12 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).
12 months post-randomization
Procedure duration
Time Frame: Day of intervention, after procedure
Duration of the procedure in minutes
Day of intervention, after procedure
Radiation dose
Time Frame: Day of intervention, after procedure
Total radiation used during procedure
Day of intervention, after procedure
Participant pain during the procedure
Time Frame: Day of intervention, after 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).
Day of intervention, after procedure
Pain intensity
Time Frame: 3 months post-randomization
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).
3 months post-randomization
Pain intensity
Time Frame: 1 month post-randomization
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).
1 month post-randomization
Pain intensity
Time Frame: 6 months post-randomization
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).
6 months post-randomization
Pain intensity
Time Frame: 12 months post-randomization
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).
12 months post-randomization
Pain interference
Time Frame: 3 months post-randomization
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).
3 months post-randomization
Pain interference
Time Frame: 1 month post-randomization
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).
1 month post-randomization
Pain interference
Time Frame: 6 months post-randomization
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).
6 months post-randomization
Pain interference
Time Frame: 12 months post-randomization
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).
12 months post-randomization
Time to receiving other procedural treatment for CLBP
Time Frame: 12 months post-randomization
From post-randomization, the number of days to receiving any other procedural treatment for CLBP
12 months post-randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life (EuroQoL 5-item)
Time Frame: 3 months post-randomization
Measured using the EuroQoL 5 Dimension (EQ-5D). The first component of the EuroQoL contains 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which has three response levels. These items produce a 0 to 1 score, with higher scores indicating better health.
3 months post-randomization
Quality of life (EuroQoL 5-item)
Time Frame: 1 month post-randomization
Measured using the EuroQoL 5 Dimension (EQ-5D). The first component of the EuroQoL contains 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which has three response levels. These items produce a 0 to 1 score, with higher scores indicating better health.
1 month post-randomization
Quality of life (EuroQoL 5-item)
Time Frame: 6 months post-randomization
Measured using the EuroQoL 5 Dimension (EQ-5D). The first component of the EuroQoL contains 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which has three response levels. These items produce a 0 to 1 score, with higher scores indicating better health.
6 months post-randomization
Quality of life (EuroQoL 5-item)
Time Frame: 12 months post-randomization
Measured using the EuroQoL 5 Dimension (EQ-5D). The first component of the EuroQoL contains 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which has three response levels. These items produce a 0 to 1 score, with higher scores indicating better health.
12 months post-randomization
Quality of life (VAS)
Time Frame: 3 months post-randomization
The second component of the EuroQOL is a visual analog scale asking participants to rate their health from 0-100, with higher ratings indicating better health.
3 months post-randomization
Quality of life (VAS)
Time Frame: 1 month post-randomization
The second component of the EuroQOL is a visual analog scale asking participants to rate their health from 0-100, with higher ratings indicating better health.
1 month post-randomization
Quality of life (VAS)
Time Frame: 6 months post-randomization
The second component of the EuroQOL is a visual analog scale asking participants to rate their health from 0-100, with higher ratings indicating better health.
6 months post-randomization
Quality of life (VAS)
Time Frame: 12 months post-randomization
The second component of the EuroQOL is a visual analog scale asking participants to rate their health from 0-100, with higher ratings indicating better health.
12 months post-randomization
Physical functioning
Time Frame: 3 months post-randomization
Measured using the PROMIS Physical Functioning SF-6B, consisting of 6 questions regarding abilities for daily functions and activities. Scores range from 0 to 100, with higher scores indicating greater function. Scores are normalized to a mean of 50 and standard deviation of 10.
3 months post-randomization
Physical functioning
Time Frame: 1 month post-randomization
Measured using the PROMIS Physical Functioning SF-6B, consisting of 6 questions regarding abilities for daily functions and activities. Scores range from 0 to 100, with higher scores indicating greater function. Scores are normalized to a mean of 50 and standard deviation of 10.
1 month post-randomization
Physical functioning
Time Frame: 6 months post-randomization
Measured using the PROMIS Physical Functioning SF-6B, consisting of 6 questions regarding abilities for daily functions and activities. Scores range from 0 to 100, with higher scores indicating greater function. Scores are normalized to a mean of 50 and standard deviation of 10.
6 months post-randomization
Physical functioning
Time Frame: 12 months post-randomization
Measured using the PROMIS Physical Functioning SF-6B, consisting of 6 questions regarding abilities for daily functions and activities. Scores range from 0 to 100, with higher scores indicating greater function. Scores are normalized to a mean of 50 and standard deviation of 10.
12 months post-randomization
Depression
Time Frame: 3 months post-randomization
Measured using the Patient Health Questionnaire (PHQ-2), consisting of 2 questions regarding frequency of depressive symptoms on a level from 0 (not at all) to 3 (nearly every day).
3 months post-randomization
Depression
Time Frame: 1 month post-randomization
Measured using the Patient Health Questionnaire (PHQ-2), consisting of 2 questions regarding frequency of depressive symptoms on a level from 0 (not at all) to 3 (nearly every day).
1 month post-randomization
Depression
Time Frame: 6 months post-randomization
Measured using the Patient Health Questionnaire (PHQ-2), consisting of 2 questions regarding frequency of depressive symptoms on a level from 0 (not at all) to 3 (nearly every day).
6 months post-randomization
Depression
Time Frame: 12 months post-randomization
Measured using the Patient Health Questionnaire (PHQ-2), consisting of 2 questions regarding frequency of depressive symptoms on a level from 0 (not at all) to 3 (nearly every day).
12 months post-randomization
Anxiety
Time Frame: 3 months post-randomization
Measured using the Generalized Anxiety Disorder Scale (GAD-2), consisting of 2 questions regarding frequency of anxiety on a level from 0 (not at all) to 3 (nearly every day).
3 months post-randomization
Anxiety
Time Frame: 1 month post-randomization
Measured using the Generalized Anxiety Disorder Scale (GAD-2), consisting of 2 questions regarding frequency of anxiety on a level from 0 (not at all) to 3 (nearly every day).
1 month post-randomization
Anxiety
Time Frame: 6 months post-randomization
Measured using the Generalized Anxiety Disorder Scale (GAD-2), consisting of 2 questions regarding frequency of anxiety on a level from 0 (not at all) to 3 (nearly every day).
6 months post-randomization
Anxiety
Time Frame: 12 months post-randomization
Measured using the Generalized Anxiety Disorder Scale (GAD-2), consisting of 2 questions regarding frequency of anxiety on a level from 0 (not at all) to 3 (nearly every day).
12 months post-randomization
Pain catastrophizing
Time Frame: 1 month post-randomization
Measured using the Pain Catastrophizing Scale (PCS) SF-6, consisting of 6 questions regarding frequency of pain catastrophizing on a level from 0 (not at all) to 4 (all the time).
1 month post-randomization
Pain catastrophizing
Time Frame: 3 months post-randomization
Measured using the Pain Catastrophizing Scale (PCS) SF-6, consisting of 6 questions regarding frequency of pain catastrophizing on a level from 0 (not at all) to 4 (all the time).
3 months post-randomization
Pain catastrophizing
Time Frame: 6 months post-randomization
Measured using the Pain Catastrophizing Scale (PCS) SF-6, consisting of 6 questions regarding frequency of pain catastrophizing on a level from 0 (not at all) to 4 (all the time).
6 months post-randomization
Pain catastrophizing
Time Frame: 12 months post-randomization
Measured using the Pain Catastrophizing Scale (PCS) SF-6, consisting of 6 questions regarding frequency of pain catastrophizing on a level from 0 (not at all) to 4 (all the time).
12 months post-randomization
Substance use (tobacco)
Time Frame: 3 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The tobacco item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
3 months post-randomization
Substance use (tobacco)
Time Frame: 1 month post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The tobacco item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
1 month post-randomization
Substance use (tobacco)
Time Frame: 6 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The tobacco item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
6 months post-randomization
Substance use (tobacco)
Time Frame: 12 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The tobacco item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
12 months post-randomization
Substance use (alcohol)
Time Frame: 3 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The alcohol item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
3 months post-randomization
Substance use (alcohol)
Time Frame: 1 month post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The alcohol item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
1 month post-randomization
Substance use (alcohol)
Time Frame: 6 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The alcohol item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
6 months post-randomization
Substance use (alcohol)
Time Frame: 12 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The alcohol item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
12 months post-randomization
Substance use (prescription drugs)
Time Frame: 3 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The prescription drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
3 months post-randomization
Substance use (prescription drugs)
Time Frame: 1 month post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The prescription drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
1 month post-randomization
Substance use (prescription drugs)
Time Frame: 6 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The prescription drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
6 months post-randomization
Substance use (prescription drugs)
Time Frame: 12 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The prescription drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
12 months post-randomization
Substance use (drugs)
Time Frame: 3 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
3 months post-randomization
Substance use (drugs)
Time Frame: 1 month post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
1 month post-randomization
Substance use (drugs)
Time Frame: 6 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
6 months post-randomization
Substance use (drugs)
Time Frame: 12 months post-randomization
Measured using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS-1) Tool, consisting of 4 multiple choice questions regarding frequency of substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). The drugs item will be evaluated as a separate outcome, where any score above 0 indicates having a positive screen.
12 months post-randomization
Global impression of change
Time Frame: 3 months post-randomization
Measured using the Patient Global Impression of Change (PGIC) scale, ranging from 1 (no change or worse) to 7 (a great deal better).
3 months post-randomization
Global impression of change
Time Frame: 1 month post-randomization
Measured using the Patient Global Impression of Change (PGIC) scale, ranging from 1 (no change or worse) to 7 (a great deal better).
1 month post-randomization
Global impression of change
Time Frame: 6 months post-randomization
Measured using the Patient Global Impression of Change (PGIC) scale, ranging from 1 (no change or worse) to 7 (a great deal better).
6 months post-randomization
Global impression of change
Time Frame: 12 months post-randomization
Measured using the Patient Global Impression of Change (PGIC) scale, ranging from 1 (no change or worse) to 7 (a great deal better).
12 months post-randomization
Sleep disturbance
Time Frame: 3 months post-randomization
Measured using the PROMIS Sleep Disturbance SF-6A, consisting of 6 multiple choice questions (each containing five levels) regarding quality of sleep. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
3 months post-randomization
Sleep disturbance
Time Frame: 1 month post-randomization
Measured using the PROMIS Sleep Disturbance SF-6A, consisting of 6 multiple choice questions (each containing five levels) regarding quality of sleep. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
1 month post-randomization
Sleep disturbance
Time Frame: 6 months post-randomization
Measured using the PROMIS Sleep Disturbance SF-6A, consisting of 6 multiple choice questions (each containing five levels) regarding quality of sleep. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
6 months post-randomization
Sleep disturbance
Time Frame: 12 months post-randomization
Measured using the PROMIS Sleep Disturbance SF-6A, consisting of 6 multiple choice questions (each containing five levels) regarding quality of sleep. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
12 months post-randomization
Sleep duration
Time Frame: 3 months post-randomization
Measured using a self-reported measure of average nightly hours of sleep from the past month.
3 months post-randomization
Sleep duration
Time Frame: 1 month post-randomization
Measured using a self-reported measure of average nightly hours of sleep from the past month.
1 month post-randomization
Sleep duration
Time Frame: 6 months post-randomization
Measured using a self-reported measure of average nightly hours of sleep from the past month.
6 months post-randomization
Sleep duration
Time Frame: 12 months post-randomization
Measured using a self-reported measure of average nightly hours of sleep from the past month.
12 months post-randomization
Opioid use
Time Frame: 3 months post-randomization
Measured using the self-reported Morphine-Equivalent Daily Dose (MED), a measure that assesses frequency and dosage of opioids.
3 months post-randomization
Opioid use
Time Frame: 1 month post-randomization
Measured using the self-reported Morphine-Equivalent Daily Dose (MED), a measure that assesses frequency and dosage of opioids.
1 month post-randomization
Opioid use
Time Frame: 6 months post-randomization
Measured using the self-reported Morphine-Equivalent Daily Dose (MED), a measure that assesses frequency and dosage of opioids.
6 months post-randomization
Opioid use
Time Frame: 12 months post-randomization
Measured using the self-reported Morphine-Equivalent Daily Dose (MED), a measure that assesses frequency and dosage of opioids.
12 months post-randomization
Patient prioritized functional limitations and activities
Time Frame: 3 months post-randomization
Measured using the Patient-Specific Functional Scale, consisting of 5 items that ask the patient to report activities they have difficulty completing due to their low back pain, rating the difficulty level of each activity from 1 (unable to complete) to 10 (able to perform at same level as before).
3 months post-randomization
Patient prioritized functional limitations and activities
Time Frame: 1 month post-randomization
Measured using the Patient-Specific Functional Scale, consisting of 5 items that ask the patient to report activities they have difficulty completing due to their low back pain, rating the difficulty level of each activity from 1 (unable to complete) to 10 (able to perform at same level as before).
1 month post-randomization
Patient prioritized functional limitations and activities
Time Frame: 6 months post-randomization
Measured using the Patient-Specific Functional Scale, consisting of 5 items that ask the patient to report activities they have difficulty completing due to their low back pain, rating the difficulty level of each activity from 1 (unable to complete) to 10 (able to perform at same level as before).
6 months post-randomization
Patient prioritized functional limitations and activities
Time Frame: 12 months post-randomization
Measured using the Patient-Specific Functional Scale, consisting of 5 items that ask the patient to report activities they have difficulty completing due to their low back pain, rating the difficulty level of each activity from 1 (unable to complete) to 10 (able to perform at same level as before).
12 months post-randomization
Pain frequency (P-FIBS)
Time Frame: 3 months post-randomization
Measured using the Pain Frequency, Intensity, and Burden Scale (P-FIBS), consisting of 4 questions rating the frequency of pain from 0 (never) to 8 (every day).
3 months post-randomization
Pain frequency (P-FIBS)
Time Frame: 1 month post-randomization
Measured using the Pain Frequency, Intensity, and Burden Scale (P-FIBS), consisting of 4 questions rating the frequency of pain from 0 (never) to 8 (every day).
1 month post-randomization
Pain frequency (P-FIBS)
Time Frame: 6 months post-randomization
Measured using the Pain Frequency, Intensity, and Burden Scale (P-FIBS), consisting of 4 questions rating the frequency of pain from 0 (never) to 8 (every day).
6 months post-randomization
Pain frequency (P-FIBS)
Time Frame: 12 months post-randomization
Measured using the Pain Frequency, Intensity, and Burden Scale (P-FIBS), consisting of 4 questions rating the frequency of pain from 0 (never) to 8 (every day).
12 months post-randomization
Pain frequency (ordinal)
Time Frame: 3 months post-randomization
Measured using the NIH Minimal Dataset (MDS) pain frequency item that measures frequency of back pain in the past 6 months, where higher scores represent more frequent pain.
3 months post-randomization
Pain frequency (ordinal)
Time Frame: 1 month post-randomization
Measured using the NIH Minimal Dataset (MDS) pain frequency item that measures frequency of back pain in the past 6 months, where higher scores represent more frequent pain.
1 month post-randomization
Pain frequency (ordinal)
Time Frame: 6 months post-randomization
Measured using the NIH Minimal Dataset (MDS) pain frequency item that measures frequency of back pain in the past 6 months, where higher scores represent more frequent pain.
6 months post-randomization
Pain frequency (ordinal)
Time Frame: 12 months post-randomization
Measured using the NIH Minimal Dataset (MDS) pain frequency item that measures frequency of back pain in the past 6 months, where higher scores represent more frequent pain.
12 months post-randomization
Concurrent analgesic use
Time Frame: 3 months post-randomization
Measured using a self-report item inquiring about pain medications (any) used in the past 24 hours. This is a binary variable (any use vs. no use in past 24 hours).
3 months post-randomization
Concurrent analgesic use
Time Frame: 1 month post-randomization
Measured using a self-report item inquiring about pain medications (any) used in the past 24 hours. This is a binary variable (any use vs. no use in past 24 hours).
1 month post-randomization
Concurrent analgesic use
Time Frame: 6 months post-randomization
Measured using a self-report item inquiring about pain medications (any) used in the past 24 hours. This is a binary variable (any use vs. no use in past 24 hours).
6 months post-randomization
Concurrent analgesic use
Time Frame: 12 months post-randomization
Measured using a self-report item inquiring about pain medications (any) used in the past 24 hours. This is a binary variable (any use vs. no use in past 24 hours).
12 months post-randomization
Pain intensity after accounting for concurrent analgesic use
Time Frame: 3 months post-randomization
Measured using a self-reported pain intensity without medications item on a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine).
3 months post-randomization
Pain intensity after accounting for concurrent analgesic use
Time Frame: 1 month post-randomization
Measured using a self-reported pain intensity without medications item on a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine).
1 month post-randomization
Pain intensity after accounting for concurrent analgesic use
Time Frame: 6 months post-randomization
Measured using a self-reported pain intensity without medications item on a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine).
6 months post-randomization
Pain intensity after accounting for concurrent analgesic use
Time Frame: 12 months post-randomization
Measured using a self-reported pain intensity without medications item on a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine).
12 months post-randomization
Physical activity (moderate vs. vigorous)
Time Frame: 3 months post-randomization
Measured using the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity Self-report, assessing frequency and time spent participating in vigorous and moderate activity in the past week. These values will be converted to moderate-equivalent minutes using the formula: Moderate-equivalent minutes = (Moderate minutes) + (Vigorous minutes × 2).
3 months post-randomization
Physical activity (moderate vs. vigorous)
Time Frame: 1 month post-randomization
Measured using the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity Self-report, assessing frequency and time spent participating in vigorous and moderate activity in the past week. These values will be converted to moderate-equivalent minutes using the formula: Moderate-equivalent minutes = (Moderate minutes) + (Vigorous minutes × 2).
1 month post-randomization
Physical activity (moderate vs. vigorous)
Time Frame: 6 months post-randomization
Measured using the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity Self-report, assessing frequency and time spent participating in vigorous and moderate activity in the past week. These values will be converted to moderate-equivalent minutes using the formula: Moderate-equivalent minutes = (Moderate minutes) + (Vigorous minutes × 2).
6 months post-randomization
Physical activity (moderate vs. vigorous)
Time Frame: 12 months post-randomization
Measured using the Behavioral Risk Factor Surveillance System (BRFSS) Physical Activity Self-report, assessing frequency and time spent participating in vigorous and moderate activity in the past week. These values will be converted to moderate-equivalent minutes using the formula: Moderate-equivalent minutes = (Moderate minutes) + (Vigorous minutes × 2).
12 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janna Friedly, MD, University of Washington
  • Principal Investigator: Pradeep Suri, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00075903
  • U01AR084723 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

We will share a complete, cleaned, de-identified copy of the locked final dataset used in conducting the final analyses upon which the accepted primary study publication is based. Data will be made available no later than when the first manuscript reporting on 12-month outcomes is published, or end of the performance period, whichever comes first. A complete dataset will be permanently archived and available through Zenodo, a generalist repository providing long-term access to and preservation of data.

IPD Sharing Access Criteria

Registered and approved users of the data must propose specific research questions in an analysis plan and sign a data use agreement (DUA). Documentation will be made available including the study protocol, the final data management and sharing plan, data dictionary/codebook, a statistical analysis plan, data collection instruments, informed consent document, and citations to the main publications based on analyses of data being deposited. For approved requests, data made available via Zenodo will include the de-identified analyzable dataset in CSV format, data variable and value labeling guidelines, and analytic code (including code used to create derived variables).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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