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| ID | Type | Description | Link |
|---|---|---|---|
| U01AR084723 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRFA-C | Active Comparator | Lumbar radiofrequency ablation with conventional electrodes |
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| LRFA-M | Active Comparator | Lumbar radiofrequency ablation with multi-tined electrodes |
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| Simulated LRFA | Sham Comparator | Simulated lumbar radiofrequency ablation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Back-related functional limitations | Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability). | 3 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Back-related functional limitations | Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability). | 1 month post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (EuroQoL 5-item) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Study Coordinator | Contact | 206-210-4040 | astralstudy@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pradeep Suri, MD | University of Washington | Principal Investigator |
| Janna Friedly, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Musculoskeletal Institute | Recruiting | Atlanta | Georgia | 30329 | United States |
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| Label | URL |
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| ASTRAL Study general information website | View source |
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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.
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.
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).
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| 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. |
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| 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. |
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| Back-related functional limitations |
Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability). |
| 6 months post-randomization |
| Back-related functional limitations | Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that evaluates patients' self-reported functional limitations due to back pain. The total score ranges from 0 (no disability) to 24 (severe disability). | 12 months post-randomization |
| Procedure duration | Duration of the procedure in minutes | Day of intervention, after procedure |
| Radiation dose | Total radiation used during procedure | Day of intervention, after procedure |
| Participant pain during the procedure | Patient low back pain intensity experienced during the procedure will be assessed within 1 hour after the procedure, using the average of (a) patient rating of average pain intensity as experienced during the procedure and (b) patient rating of worst pain intensity as experienced during the procedure. The scale for each of these two items ranges from 0 (no pain) to 10 (worst pain imaginable). | Day of intervention, after procedure |
| Pain intensity | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 3 months post-randomization |
| Pain intensity | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 1 month post-randomization |
| Pain intensity | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 6 months post-randomization |
| Pain intensity | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain intensity item, asking about low back pain specifically. The scale ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | 12 months post-randomization |
| Pain interference | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference). | 3 months post-randomization |
| Pain interference | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference). | 1 month post-randomization |
| Pain interference | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference). | 6 months post-randomization |
| Pain interference | Measured using the Pain, Enjoyment of Life, and General Activity (PEG) Scale pain interference item, asking about interference due to low back pain specifically. The scale ranges from 0 (no interference) to 10 (complete interference). | 12 months post-randomization |
| Time to receiving other procedural treatment for CLBP | From post-randomization, the number of days to receiving any other procedural treatment for CLBP | 12 months post-randomization |
| Quality of life (EuroQoL 5-item) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Measured using a self-reported measure of average nightly hours of sleep from the past month. | 3 months post-randomization |
| Sleep duration | Measured using a self-reported measure of average nightly hours of sleep from the past month. | 1 month post-randomization |
| Sleep duration | Measured using a self-reported measure of average nightly hours of sleep from the past month. | 6 months post-randomization |
| Sleep duration | Measured using a self-reported measure of average nightly hours of sleep from the past month. | 12 months post-randomization |
| Opioid use | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| University of Utah Orthopaedic Center/PM&R | Not yet recruiting | Salt Lake City | Utah | 84108 | United States |
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