Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- intermittent theta burst stimulation
- LoveYourBrain Yoga Program
Treatment groups
213 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov