Status:
NOT_YET_RECRUITING
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Low Back Pain
Musculoskeletal Pain
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief 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-e...
Detailed Description
Significance to VA: Chronic low back pain (CLBP) is the leading cause of disability worldwide and the most common location of chronic pain among Veterans. Medications are the treatment mainstay for CL...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT07158567
Start Date
June 1 2026
End Date
December 31 2031
Last Update
September 8 2025
Active Locations (2)
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1
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
2
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030