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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Chronic Low Back Pain, Musculoskeletal Pain

In brief

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.

Key facts

Study ID

NCT07158567

Run by

VA Office of Research and Development

People needed

213

Starts

2026-08-01

Expected to finish

2031-12-31

Last updated by the study team

2026-07-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1 month stability in pain management strategies.
• 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).

You may not qualify if…

• 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 disorders).
• Active suicidal ideation with Columbia Suicide Severity Rating Scale(CSSRS) 3 .
• Are pregnant or nursing.
• Within 12 weeks of a major surgery/operation.

Where it is running

• Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States

Full record on ClinicalTrials.gov

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