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Clinical Trial Summary

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).


Clinical Trial Description

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), and inflammatory cytokines (CRP, IL and TNF). 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. We also hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly decreased inflammatory cytokines (CRP, IL and TNF) levels at 8-weeks follow up than older adults randomized to the sham mindfulness-based meditation group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06384001
Study type Interventional
Source Florida State University
Contact Jie Chen
Phone (850) 645-0657
Email jc22db@fsu.edu
Status Not yet recruiting
Phase N/A
Start date May 2024
Completion date December 2025

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