Research Letter: Safety, Feasibility, Acceptability and Preliminary Findings From Veterans' Intervention Blending NeuRomodulation and YogA for Chronic PaiN Treatment: VIBRANT-MTBI and Chronic Pain Pilot.

Abstract

Objectives: To examine the feasibility, acceptability, safety, and preliminary findings of a blended intermittent theta burst stimulation and LoveYourBrain (LYB) Yoga (iTBS + LYByoga) intervention for improving pain among Veterans with chronic mild traumatic brain injury and chronic musculoskeletal pain (mTBI + CP).

Setting: Single VA hospital.

Participants: Nineteen Veterans (68.4% men) with mTBI + CP enrolled. Fourteen Veterans met full eligibility criteria and initiated iTBS + LYByoga.

Design: Single group, open-label, mixed methods, pilot clinical trial of iTBS + LYByoga. Participants received iTBS to the motor cortex at 80% of the motor threshold immediately followed by group LYB Yoga once a week for 6 weeks.

Main measures: To assess feasibility, intervention completion rates were assessed post-treatment. To assess safety, adverse events and 17 safety indicators were collected at each intervention session. To assess acceptability, self-reported satisfaction ratings, and semi-structured qualitative interviews were assessed post-treatment. To assess preliminary outcomes, the Brief Pain Inventory (BPI) was completed pre- and post-treatment: pain severity and pain interference scores were computed.

Results: Nineteen Veterans enrolled and 14 initiated the intervention. Our sample had a 71.4% (10/14) completion rate for all 6 sessions. There were no serious adverse events. The most common side effect was headaches experienced by 3 Veterans. The self-report satisfaction ratings indicated that most Veterans (60%) rated the quality of the program "excellent." Qualitative interview data support these feasibility and acceptability findings. Mean self-reported pain severity via the BPI significantly improved (P = .0026) between pre-treatment and post-treatment (Cohen's d effect size = 1.3). Mean self-reported pain interference from the BPI did not change (P = .0609) between pre-treatment and post-treatment (Cohen's d effect size = .7).

Conclusions: Lack of serious adverse events suggests that the iTBS + LYByoga intervention is safe among veterans with mTBI + CP. The program's feasibility and acceptability coupled with improvements in self-reported pain outcomes warrants further research in a larger, randomized control trial.