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

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.

Conditions

• Chronic Low Back Pain
• Musculoskeletal Pain

Interventions

DEVICE

intermittent 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.

BEHAVIORAL

LoveYourBrain 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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Amy A Herrold, PhD BA · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2031-06-01

Completion

2031-12-31

FDA Device

Yes

Countries

• United States

Study Locations