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MBM and taVNS for Low Back Pain and Depressive Symptoms

  • Recruiting
Principal Investigators: Jie Chen

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.

For additional information, please visit www.clinicaltrials.gov  or click on the following link:

Clinical Trials ID: NCT07415941

Primary Objectives

To test the preliminary effect of home-based mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS) on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms.

Procedure

Active Comparator: Mindfulness-based meditation (MBM) is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks. Experimental: back-to-back taVNS and MBM; The VNSM includes a single daily session, five days per week, consisting of back-to-back 20-minute taVNS immediately followed by 20-minute MBM (total ≈ 40 minutes).

Eligibility Criteria

Inclusion

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

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.
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