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Not Yet Recruiting NCT07158567

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

Conditions: Chronic Low Back Pain, Musculoskeletal Pain

Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 213
Sponsor: VA Office of Research and Development

Location: Jesse Brown VA Medical Center, Chicago, IL Chicago Illinois

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.

Eligibility Criteria

Inclusion Criteria: * 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 Brief Pain Inventory (BPI) demonstrating disability of at least 20% on the Oswestry Disability Index (ODI) Exclusion Criteria: * Contraindications to combined intermittent theta burst (iTBS)/transcranial magnetic stimulation (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 traumatic brain injury (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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07158567). StuddyBuddy aggregates publicly available trial information.