Meditation for Older Adults With Chronic Low Back Pain

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06384001
Status
Recruiting

Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Active MBM — BEHAVIORAL
    The MBM is designed to be applied for 20 minutes per session daily for two weeks. The recording will instruct participants to close their eyes, connect to the openness of one's minds, and mindfully maintain and deepen the connection through breathing with more openness and awareness. The MBM intervention will include three recordings that gradually take the participant into a more profound meditation practice. Participants will be instructed to listen to Meditation 1 for the first three days of the intervention, then switch to Meditation 2 for days 4-6 and Meditation 3 for the remainder of the 2-week intervention. The participants will be asked to practice meditation for eight weeks (6 weeks after the initial two weeks of MBM practice).
  • Sham MBM — BEHAVIORAL
    The sham MBM intervention was also recorded. The sham recording will instruct participants to relax and take deep breaths every 3 minutes without the specific mindfulness-based instructions (e.g., practicing mindful attention to the breath in a non-evaluative manner). All other aspects of the sham MBM intervention (e.g., body position, time spent listening to instructions, eyes closed) will match the active MBM.

Study Details

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).

Key Dates

Start date
Sep 24, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Active MBM
    The active MBM is designed to be applied for 20 minutes per session daily.
  • Sham Comparator: Sham MBM
    The sham MBM intervention matches the active MBM

Primary Outcome Measure

Change in pain intensity and interference [ Time Frame: Baseline and 2 weeks and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32308
Sharon Liebrich
850-645-6887
Jie Chen (PRINCIPAL_INVESTIGATOR)

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