Not Yet RecruitingPhase 3

Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT

United States213 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1 mo. stability in pain management strategies. * 22+ years of age. * Can read and speak English. * Able to participate in strengthening, stretching, range of motion exercise via yoga as determined by study physician. * Chronic Low Back Pain (CLBP): pain in the low back that persists for \>6 months and is of moderate to severe intensity with a score of \>5 on specific items on the BPI demonstrating disability of at least 20% on the Oswestry Disability Index (ODI). Exclusion Criteria: * Contraindications to iTBS/TMS (e.g. epilepsy, psychotic spectrum disorders \[i.e. bipolar, schizophrenia\], history of anoxic brain injury). * Moderate to severe heart disease. * Contraindications to MRI (e.g., claustrophobia, implanted ferromagnetic device such as pacemaker or cardiac defibrillator). * Pain believed to be associated with cardiac or ischemic conditions. * Epilepsy, active seizure disorder, personal history of a seizure or individuals with a family history of epilepsy or seizure in a first degree relative. * Current prescription of psychostimulants (e.g., amphetamines), anticholinergics, tricyclic antidepressants, and antipsychotics or other medications that may increase their risk of having seizures. * Intracranial lesion. * History of ischemic or hemorrhagic stroke. * History of moderate to severe TBI. * History of or current psychosis not due to an external cause (e.g., due to illicit drug use). * Other neurological conditions (e.g., neurodegenerative …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial combining neuromodulation and yoga for chronic low back pain — can you explain what neuromodulation involves in this context, and whether you think that combination makes sense for my specific situation?
2The trial isn't recruiting yet, so if it does open and I'm interested, how would I get on a list to be notified, and is my condition stable enough that waiting could make sense?
3The study is measuring pain severity and how much pain interferes with daily life using the Brief Pain Inventory — are those the outcomes that matter most for my situation, or are there other factors like function or medication use that should also be driving my treatment decisions right now?
4Since this trial is specifically for veterans, do I meet that eligibility requirement, and are there similar studies open to non-veterans if that's relevant to me?
5Before considering a trial like this, should I try standard treatments for chronic low back pain first — like physical therapy, medication, or established interventional procedures — and would pursuing those now affect my eligibility later if I wanted to enroll?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brief Pain Inventory - Pain Severity

Timeframe: Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment

Brief Pain Inventory - Pain Interference

Timeframe: Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment

Trial details

NCT IDNCT07158567

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2031-06-01

Contact for this trial

Amy A Herrold, PhD BA

(708) 202-5867 amy.herrold@va.gov

View on ClinicalTrials.gov More Chronic Low Back Pain trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Brief Pain Inventory - Pain Severity

Timeframe: Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment

Brief Pain Inventory - Pain Interference

Timeframe: Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment