Mindfulness + Vagus Nerve Stimulation for Chronic Lower Back Pain and Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation for managing pain and depressive symptoms
Follow-up
Participants are monitored for changes in pain intensity, depressive symptoms, and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MBM
- taVNS
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The VNSM includes a single daily session, five days per week, consisting of back-to-back 20-minute taVNS immediately followed by 20-minute MBM (total ≈ 40 minutes).
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
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