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NCT06384001NARecruiting

Meditation for Older Adults With Chronic Low Back Pain

Florida State University

Start Date

9/24/2025

Completion Date

12/1/2026

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).

Detailed 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). 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.

Eligibility Criteria

Age Range: 50 years to 89 years

Inclusion Criteria: 1. aged 50 years older 2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24) 3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\]) 4. able to speak and read English 5. not intent to change medication regimens for pain throughout the trial Exclusion Criteria: 1. serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy) 2. psychosis 3. function limitation precluded the meditation practice 4. participated meditation program before 5. no access to the internet

Interventions

BEHAVIORAL

Active MBM

BEHAVIORAL

Sham MBM

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Conditions

Chronic Low Back Pain

Locations

Florida State University

Tallahassee, Florida 32308

United States