MBM and taVNS for Low Back Pain and Depressive Symptoms
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 im