Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low Back PaiN Treatment: VIBRANT
VA Office of Research and Development
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.
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 CLBP and yet \>50% of chronic pain patients receiving medications are treatment resistant. Lack of pain relief from medications can lead to non-prescription opioid use, opioid use disorder, and Veteran death from opioid overdose, which occurs at a higher rate than US Civilians. This Merit will directly benefit Veterans and VA Services by developing a new, neuromodulatory, non-opioid neurorehabilitat…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Contraindications to iTBS/TMS (e.g. epilepsy, psychotic spectrum disorders \[i.e. bip…
Interventions
- Deviceintermittent theta burst stimulation
Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulatory treatment. TMS has been FDA cleared since 2008 for treatment resistant depression. It is now FDA cleared for a few other indications including migraine. Magnetic pulses are delivered through a coil placed on the scalp and when the magnetic field reaches brain cells, it changes to an electric current that can increase or decrease excitability depending on the treatment parameters. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS only takes 3 minutes to deliver and is theorized to induce a window of neuroplasticity that lasts at least 1 hour. The Magventure with Magoption x100 Stimulator and associated coil the investigators are using can be set to deliver active (real) or sham (fake or inactive) TMS. The sham device is designed to look, sound and feel like real TMS.
- BehavioralLoveYourBrain Yoga Program
This yoga program is evidence-based, standardized and manualized. It is developed by the LoveYourBrain Foundation (www.loveyourbrain.com). Each yoga session includes 10 min of breathing exercises, 45 min of gentle yoga or stretching exercises, 15 min of guided meditation, and 20 min of facilitated discussion with psychoeducation, detailed in a manual to ensure standardization of program content across time and instructors.
Locations (2)
- Jesse Brown VA Medical Center, Chicago, ILChicago, Illinois
- Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois