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MBM and taVNS for 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests home-based mindfulness meditation and gentle electrical stimulation of a nerve through the skin of the ear for low back pain and depression symptoms. It is for adults ages 50 to 85 who live in the community and have both symptoms. It also looks at effects on the link between the brain and gut.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 50 to 85 years old.
  • Score at least 24 on a test of memory and thinking skills.
  • Have low back pain daily or almost daily for at least 3 months, rated at least 3 out of 10.
  • Score 5 to 19 on the PHQ-9 questionnaire about depression symptoms.
  • Can speak and read English.
  • Do not plan to change pain medicines during the study.

Who can't join

  • Have a serious illness, such as cancer.
  • Have psychosis, a condition that affects your sense of what is real.
  • Have a higher suicide risk, shown by a score above 2 on the C-SSRS suicide risk test.
  • Have limits in your ability to function that prevent meditation practice.
  • Have taken part in a meditation program before.
  • Have a condition that prevents safe use of the ear nerve stimulation, such as past or current heart or blood vessel problems, a recent ear injury, or metal implants above the neck.
  • Do not have internet access.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 implants above the level of the neck, 7. no access to the internet.

Study sites (1)

FL