RecruitingNot ApplicableNCT07415941

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

Sponsor

Florida State University

Enrollment

66 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain

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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests two non-drug treatments for older adults who have both chronic low back pain and symptoms of depression: mindfulness-based movement (MBM) and a gentle nerve stimulation technique called transcutaneous auricular vagus nerve stimulation (taVNS), which uses a small device on the ear. **You may be eligible if...** - You are 50 to 85 years old - You have normal or near-normal cognitive function - You experience moderate low back pain most days for at least 3 months - You have elevated depressive symptoms **You may NOT be eligible if...** - You have significant cognitive impairment - Your pain or depression does not meet the study thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMBM

MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.

DEVICEVNSM

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.