MBM and taVNS for Low Back Pain and Depressive Symptoms
Recruiting · NCT07415941 · Interventional (participants receive a specific treatment) · Lead sponsor: Florida State University
View the official record on ClinicalTrials.gov →Interventions studied
MBMVNSM
What this trial is about
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.
Who can take part
Age range
50 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- able to speak and read English
- not intent to change medication regimens for pain throughout the trial.
Exclusion criteria
- 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,
- participated meditation program before,
- 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,
- no access to the internet.
Where it is running
1 location listed across 1 US state.
- Florida State University - Tallahassee, Florida, United States