MBM and taVNS for Low Back Pain and Depressive Symptoms
Recruiting now · Not applicable
Conditions studied: Chronic Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT07415941
- Run by
- Florida State University
- People needed
- 66
- Starts
- 2026-01-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-25
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- aged 50 to 85 years old
- intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
- 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])
- experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19
- able to speak and read English
- not intent to change medication regimens for pain throughout the trial.
You may not qualify if…
- serious underlying illness (e.g., malignant neoplasms),
- other psychosis,
- elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score > 2,
- function limitation precluded the meditation practice,
- participated meditation program before,
- 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,
- no access to the internet.
Where it is running
- Florida State University — Tallahassee, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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