MBM and taVNS for Low Back Pain and Depressive Symptoms
RecruitingNot applicableNCT07415941
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
- Conditions
- Interventions
- Behavioral: MBM
- Device: VNSM
- Sponsor
- Florida State University
- Start date
- 2026-01-30
- Primary completion
- 2027-12-31
- Sex
- All
- Age range
- from 50 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 implants above the level of the neck, 7. no access to the internet.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07415941