Recruiting

MBM and taVNS for Low Back Pain and Depressive Symptoms

This two-arm randomized controlled trial aims to test the preliminary effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms; and the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

ClinicalTrials.gov IDNCT07415941

PhaseNA

Enrollment66

SponsorFlorida State University

Age50 Years

SexALL

I'm interested View official listing

Conditions studied

Chronic Low Back Pain

About this study

Interventions

Behavioral: MBM — MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
Device: VNSM — The VNSM consists of a single daily session, five days per week, comprising 20 minutes of taVNS immediately followed by 20 minutes of MBM (total ≈ 40 minutes) for 8 weeks.

Primary outcomes

Change in pain intensity and interference (Baseline and 2 weeks and 8 weeks)
Change in depressive symptoms (Baseline and 2 weeks and 8 weeks)

Eligibility information

Inclusion Criteria: 1. aged 50 to 85 years old 2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24) 3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\]) 4. experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19 5. able to speak and read English 6. not intent to change medication regimens for pain throughout the trial. Exclusion Criteria: 1. serious underlying illness (e.g., malignant neoplasms), 2. other psychosis, 3. elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score \> 2, 4. function limitation precluded the meditation practice, 5. participated meditation program before, 6. any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck, 7. no access to the internet.

Study locations

Florida State University, Tallahassee, Florida 32306 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.