Mindfulness meditation plus ear vagus nerve stimulation for chronic low back pain and depressive symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Florida State University
  Tallahassee, Florida, United States Recruiting

Study contacts

• Study coordinator: Jie Chen
• Email: jc22db@fsu.edu
• Phone: 18506450657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.