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 groupsSponsors and collaborators
Source ClinicalTrials.gov