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