Health Trials

MBM and taVNS for Low Back Pain and Depressive Symptoms

ConditionChronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorFlorida State University

About this trial

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.

Eligibility criteria

Qualifiers

aged 50 to 85 years old

intact cognition (examined by the Mini-Mental State Exam, ≥ 24)

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])

experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19

Disqualifiers

serious underlying illness (e.g., malignant neoplasms),

other psychosis,

elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score > 2,

function limitation precluded the meditation practice,

Trial design

Treatments tested in this trial

  • MBM
  • VNSM

Treatment groups

66 Participants
are divided into 2 treatment groups

Locations

1
Florida State University32306, TallahasseeFlorida, United States

Sponsors and collaborators

Florida State University

Lead sponsor

Source ClinicalTrials.gov