NCT07415941

MBM and taVNS for Low Back Pain and Depressive Symptoms

Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objective: To test the preliminary effect of home-based mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS) on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms. Secondary Objective(s): To test the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-17
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study