Meditation for Older Adults With Chronic Low Back Pain

Last updated: April 28, 2025
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Active MBM

Sham MBM

Clinical Study ID

NCT06384001
STUDY00004032
  • Ages 50-89
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 previousthree 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

Exclusion Criteria:

  1. serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low bloodplatelet count, been in chemotherapy)

  2. other concurrent chronic pain conditions (e.g., arthritis, headache, irritable bowelsyndrome)

  3. psychosis

  4. inflammatory or malabsorptive intestinal diseases

  5. function limitation precluded the meditation practice

  6. participated meditation program before

  7. no access to the internet

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Active MBM
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Florida State University

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

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