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NCT07158567 · ClinicalTrials.gov registry record · Phase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
A Phase 3 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 3
- Development phase
- 213
- Enrollment target
NCT07158567: Clinical Trial Phase 3 study, sponsored by VA Office of Research and Development.
NCT07158567 is a Phase 3 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 213 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07158567, a Phase 3 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 213 participants
- Enrollment target
Study Summary
The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit project will directly benefit Veterans and VA Services by demonstrating efficacy of a new, non-medication treatment for Veterans with CLBP in need of non-opioid treatment options. Neuromodulation including iTBS is now offered at over 50 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-medication treatment for Veterans with CLBP is of great need given the high prevalence of CLBP.
Primary Outcome
The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items related to pain severity and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 40.
Interventions
- DEVICE intermittent theta burst stimulation
- BEHAVIORAL LoveYourBrain Yoga Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 3 |
What is known before NCT07158567 opens enrollment
NCT07158567 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which intermittent theta burst stimulation is the first listed.
NCT07158567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07158567 about?
NCT07158567 is a clinical study titled "Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT". The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit...
What is the current status of trial NCT07158567?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 213 participants. The study started on 2026-07-01. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07158567?
The interventions under investigation include: intermittent theta burst stimulation (DEVICE), LoveYourBrain Yoga Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT07158567?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07158567's enrollment target sits among peer trials
213 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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