Mindfulness meditation plus ear vagus nerve stimulation for chronic 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
This study will test whether a home-based mindfulness meditation program combined with gentle ear vagus nerve stimulation can reduce pain and depressive symptoms in community-dwelling older adults with chronic low back pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07415941 on ClinicalTrials.gov |
What this trial studies
This is a two-arm randomized controlled trial comparing home-based mindfulness-based meditation (MBM) with transcutaneous auricular vagus nerve stimulation (taVNS) delivered to older adults living in the community who have chronic low back pain and elevated depressive symptoms. Eligible participants are aged 50–85, have intact cognition, report moderate daily low back pain for at least three months, and have PHQ-9 scores of 5–19. The primary outcomes are changes in pain intensity and depressive symptom scores; secondary outcomes examine effects on the host brain–gut axis. Interventions are self-administered at home with study oversight and periodic visits at Florida State University for assessments.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 50–85 with at least three months of moderate or worse low back pain (≥3/10), mild-to-moderate depressive symptoms (PHQ-9 5–19), intact cognition, and no intent to change pain medications during the trial.
Not a fit: People with severe medical illness, psychosis, elevated suicide risk, significant cognitive impairment, prior meditation program participation, or contraindications to taVNS (e.g., cardiovascular disorders or recent ear trauma) may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a non-drug, home-administered option to help reduce chronic low back pain and depressive symptoms in older adults.
How similar studies have performed: Mindfulness programs have demonstrated benefits for chronic pain and mood in multiple prior studies, while home-based transcutaneous auricular VNS is a newer approach with limited but promising early evidence.
Eligibility criteria
Show full inclusion / exclusion 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 implants above the level of the neck, 7. no access to the internet.
Where this trial is running
Tallahassee, Florida
- Florida State University — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Jie Chen
- Email: jc22db@fsu.edu
- Phone: 18506450657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.