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NCT Number: NCT07222462

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.

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Key information

Conditions

Chronic Low Back Pain (CLBP)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Musculoskeletal Institute, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)

Procedure

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

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 ablation

Procedure

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Procedure duration

    Time frame: Day of intervention, after procedure

    Duration of the procedure in minutes

  5. Radiation dose

    Time frame: Day of intervention, after procedure

    Total radiation used during procedure

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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).

  42. 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).

  43. 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).

  44. 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).

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. Sleep duration

    Time frame: 3 months post-randomization

    Measured using a self-reported measure of average nightly hours of sleep from the past month.

  50. Sleep duration

    Time frame: 1 month post-randomization

    Measured using a self-reported measure of average nightly hours of sleep from the past month.

  51. Sleep duration

    Time frame: 6 months post-randomization

    Measured using a self-reported measure of average nightly hours of sleep from the past month.

  52. Sleep duration

    Time frame: 12 months post-randomization

    Measured using a self-reported measure of average nightly hours of sleep from the past month.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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).

  58. 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).

  59. 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).

  60. 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).

  61. 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).

  62. 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).

  63. 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).

  64. 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).

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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).

  70. 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).

  71. 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).

  72. 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).

  73. 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).

  74. 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).

  75. 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).

  76. 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).

  77. 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).

  78. 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).

  79. 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).

  80. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Research Study Coordinator

CONTACT

[email protected]

206-210-4040

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

ASTRAL: A Superiority Trial of Radiofrequency Ablation for Low Back Pain

Acronym: ASTRAL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 29, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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