An interventional study of Lumbar medial branch nerve radiofrequency ablation (LRFA) and Simulated LRFA with targeted steroid injections in Low Back Pain, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Back pain is the #1 contributor to disability in the United States (US), and second only to hearing problems as a reason for new Veteran disability compensation. The societal burden of back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain persisting for 3 months. Since most individual treatments for CLBP have only small effects on functional recovery, combining CLBP treatments has recently been recommended as a priority area for research. However, few prior studies of CLBP have been properly designed to evaluate the effects of treatment combinations. Large effects on functional recovery from CLBP may require combining interventions that each target different points on a theoretical pathway to functional recovery. Procedural treatments for CLBP aim primarily to address early stages in the pathway to functional recovery, such as problems with the lumbar spinal structures or low back pain itself. In contrast, behavioral interventions for CLBP generally have effects not only on pain itself, but also work by mitigating the degree to which the sensation of low back pain impacts function, well-being, and quality of life. These represent later stages in the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments may have great potential for achieving large magnitude treatment effects for CLBP in Veterans.
The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA treatment to be used in the proposed study addresses the major patient selection, procedural/technical, methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT) delivered in clinic, and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT. This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary outcome. The primary outcome is participant-reported back-related functional limitations (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain intensity, reduction in opioid use, and quality of life. Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery, it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.
The proposed research assesses the feasibility of using an innovative application of the 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA treatment to be used in the proposed study addresses the major patient selection, procedural/technical, methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT) delivered in clinic, and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT. This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary outcome. The primary outcome is participant-reported back-related functional limitations (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain intensity, reduction in opioid use, and quality of life. The investigators hypothesize that 1) each individual treatment will result in improvements in back-related functional limitations and secondary outcomes compared to control, and 2) combined treatment will produce greater treatment effects than each of the individual treatments alone. Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery, it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves
Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)
Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections
Procedure: Simulated LRFA with targeted steroid injections
Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT)
Behavioral: AcTIVE-CBT
Telephone-based self-directed CBT and education (TBSCE)
Behavioral: TBSCE
Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
Also known as: Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections to the medial branch nerves.
AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
Also known as: Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT).
TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
Also known as: Telephone-based supportive contact and education (TBSCE)
Roland-Morris Disability Questionnaire
The RMDQ is a validated, commonly used, and widely accepted 'legacy' measure of back-related functional limitations (range 0 to 24, with higher scores representing greater functional limitations).
Time frame: 3 months
Activity Tracker-assessed Average Daily Step Counts (Change Scores)
Change scores will be calculated as compared to average daily step count pre-randomization.
Time frame: 3 months
Low Back Pain Intensity (0-10 Numerical Pain Rating Scale)
Higher numerical pain ratings reflect greater pain intensity.
Time frame: 3 months
PROMIS Global Health Short Form 10
Global quality of life measure. There are two subscales, the physical component summary score and the mental component summary score. Each range from 4-20, with higher scores reflecting greater quality of life
Time frame: 3 months
Average Morphine Equivalent Daily Dose
Self-reported average morphine equivalent daily dose over the past 3 days.
Time frame: 3 months
Global Perceived Effect (How Back Pain Has Changed Since Baseline)
7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever'
Time frame: 3 months
Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications
Higher numerical pain ratings reflect greater pain intensity.
Time frame: 3 months
Participant-reported Satisfaction
5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied'
Time frame: 3 months
BRFSS Self-reported Physical Activity Per Week
Self-reported activity equivalent minutes per week
Time frame: 3 months
Recruitment dates: 11/15/2018 to 03/17/2020 at the VA Puget Sound Health Care System
| Milestone | Pre-Randomization Run-In Period | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|---|
| Started | 16 | 0 | 0 | 0 | 0 |
| Completed | 13 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Failed eligibility criteria or run-in period criteria | 2 | 0 | 0 | 0 | 0 |
| Milestone | Pre-Randomization Run-In Period | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|---|
| Started | 0 | 4 | 3 | 3 | 3 |
| Completed | 0 | 4 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
The RMDQ is a validated, commonly used, and widely accepted 'legacy' measure of back-related functional limitations (range 0 to 24, with higher scores representing greater functional limitations).
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Roland-Morris Disability Questionnaire | 9.8 ± 4.1 | 5.3 ± 5.9 | 13.3 ± 3.1 | 16.7 ± 4.2 |
Change scores will be calculated as compared to average daily step count pre-randomization.
| average daily step count change score | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Activity Tracker-assessed Average Daily Step Counts (Change Scores) | -1445.8 ± 5984.0 | 5617.2 ± 5963.4 | 42.02 ± 448.3 | -842.4 ± 3105.5 |
Higher numerical pain ratings reflect greater pain intensity.
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) | 4.8 ± 4.5 | 4.7 ± 1.2 | 4.7 ± 3.5 | 5.3 ± 1.5 |
Global quality of life measure. There are two subscales, the physical component summary score and the mental component summary score. Each range from 4-20, with higher scores reflecting greater quality of life
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| PROMIS physical health | 40.5 ± 5.2 | 44.3 ± 5.8 | 37.4 ± 9.3 | 38.2 ± 3.8 |
| PROMIS mental health | 47.8 ± 5.4 | 50.9 ± 5.1 | 55.3 ± 4.2 | 38.6 ± 7.3 |
Self-reported average morphine equivalent daily dose over the past 3 days.
| average morphine milligram equivalents | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Average Morphine Equivalent Daily Dose | 0 ± 0 | 0 ± 0 | 0 ± 0 | 6.7 ± 5.8 |
7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever'
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Global Perceived Effect (How Back Pain Has Changed Since Baseline) | 0.3 ± 1.7 | 0.7 ± 0.6 | 0.7 ± 1.2 | 0 ± 0 |
Higher numerical pain ratings reflect greater pain intensity.
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications | 5.0 ± 4.2 | 5.0 ± 1.7 | 5.7 ± 4.0 | 7.0 ± 1.7 |
5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied'
| units on a scale | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| Participant-reported Satisfaction | 1.0 ± 1.4 | 0.3 ± 0.6 | 0.3 ± 1.5 | -1.3 ± 0.6 |
Self-reported activity equivalent minutes per week
| activity minutes per week | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) |
|---|---|---|---|---|
| BRFSS Self-reported Physical Activity Per Week | 487.5 ± 306.2 | 1650.0 ± 297.0 | 201.7 ± 97.8 | 398.3 ± 530.1 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Randomizaton Run-In Period | 0/16 (0%) | 0/16 (0%) | 5/16 (31.3%) |
| Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Pre-Randomizaton Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE |
|---|---|---|---|---|---|
| Allergic ReactionImmune system disorders | 0/16 | 3/4 | 0/3 | 0/3 | 0/3 |
| ED/Urgent CareSurgical and medical procedures | 5/16 | 0/4 | 1/3 | 2/3 | 0/3 |
| Other ComplicationsGeneral disorders | 0/16 | 1/4 | 1/3 | 1/3 | 0/3 |
| SurgerySurgical and medical procedures | 0/16 | 1/4 | 0/3 | 0/3 | 0/3 |
| HospitalizationSurgical and medical procedures | 0/16 | 0/4 | 0/3 | 0/3 | 0/3 |
| ICUSurgical and medical procedures | 0/16 | 0/4 | 0/3 | 0/3 | 0/3 |
At randomization, participants are randomized to 1 the 4 treatment groups above; thus there are 0 participants in the "Pre-Randomization Run-In Period" group. Although baseline characteristics presented for each cell of the 2 x 2 contingency table in this factorial pilot trial, the primary analysis as originally planned focused on the main effects of (1) LRFA vs. simulated LRFA and (2) AcTIVE-CBT vs. TBSCE, unless there were indications of strong interactions between the two types of treatment.
| Age, Continuous(years) | Pre-Randomization Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Total |
|---|---|---|---|---|---|---|
| Mean | — | 59.3 ± 14.6 | 57.7 ± 14.6 | 66.0 ± 14.1 | 49.3 ± 3.5 | 58.2 ± 12.6 |
| Sex: Female, Male(Participants) | Pre-Randomization Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Total |
|---|---|---|---|---|---|---|
| Female | — | 0 | 0 | 0 | 0 | 0 |
| Male | — | 4 | 3 | 3 | 3 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Pre-Randomization Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | — | 2 | 1 | 0 | 0 | 3 |
| Not Hispanic or Latino | — | 2 | 2 | 3 | 3 | 10 |
| Unknown or Not Reported | — | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pre-Randomization Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 | 0 | 0 | 0 |
| Asian | — | 0 | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 | 0 | 0 | 0 |
| Black or African American | — | 0 | 0 | 0 | 0 | 0 |
| White | — | 3 | 1 | 2 | 3 | 9 |
| More than one race | — | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | — | 1 | 0 | 0 | 0 | 1 |
| Back-related functional limitations, RMDQ (pre-randomization)(units on a scale) | Pre-Randomization Run-In Period | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Total |
|---|---|---|---|---|---|---|
| Mean | — | 16.3 ± 3.6 | 10.0 ± 3.6 | 14.0 ± 1.0 | 16.0 ± 2.7 | 14.2 ± 3.7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Only completely deidentified/anonymized versions of datasets would be shared, provided that appropriate enterprise-level procedures permit this and are in place. Sharing would only take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset, including a properly submitted FOIA request. Electronic versions of final data sets will be maintained locally in a secure manner until enterprise-level resources become available for long-term storage.
Supporting information: Study protocol, Sap, Icf, Analytic code
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