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Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA).
Aim 1: to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain. Hypothesis: We hypothesize that our active mindfulness-based meditation intervention will be feasible and acceptable to community-dwelling older adults with chronic low back pain and improve pain and symptoms to a greater extent than older adults randomized to a sham mindfulness-based meditation group. Aim 2: to test the effect of the mindfulness-based meditation intervention on the host Gut-Brain Axis (GBA). Hypothesis: We hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly improved compositional patterns and functional profiles of gut microbiota and increased pain-related cortical response measured by functional near-infrared spectroscopy (fNIRS) to a greater extent than older adults randomized to the sham mindfulness-based meditation group at 2-weeks post-intervention, and 8-weeks follow up.
Age
50 - 89 years
Sex
ALL
Healthy Volunteers
No
Florida State University
Tallahassee, Florida, United States
Start Date
September 24, 2025
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
October 22, 2025
66
ESTIMATED participants
Active MBM
BEHAVIORAL
Sham MBM
BEHAVIORAL
Lead Sponsor
Florida State University
NCT03836248
NCT07132762
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06419439