Actively Recruiting
Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-Brain Axis: A Pilot Randomized Controlled Trial
Led by Florida State University · Updated on 2025-10-22
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a mindfulness-based meditation (MBM) program on older adults living in the community who experience chronic low back pain. This pilot randomized controlled trial aims to study how MBM influences pain, symptoms, and the Gut-Brain Axis (GBA) in individuals aged 50 to 89 years. The study also compares the active meditation intervention to a sham meditation to assess feasibility, acceptability, and potential benefits. The study includes two groups: one practicing active MBM and the other following a sham MBM intervention. Participants in the active group will meditate daily for 20 minutes using guided recordings that deepen meditation practice over two weeks, followed by six additional weeks of continued meditation practice. The sham group will listen to recordings that encourage relaxation and deep breathing without mindfulness instructions, matching the active group in time and setting. Participants will be followed for eight weeks, with evaluations at baseline, two weeks, and eight weeks. Measurements include changes in pain intensity and interference, pain sensitivities and modulation, anxiety, depression, fatigue, sleep disturbance, and pain-related brain responses using functional near-infrared spectroscopy. Researchers will also analyze gut microbiota diversity and abundance from fecal samples to explore the Gut-Brain Axis. The study monitors symptoms and collects self-reported data to assess the impact of meditation on chronic pain and related factors.
CONDITIONS
Brief Title
Meditation for Older Adults With Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years or older
- Intact cognition with Mini-Mental State Exam score of 24 or higher
- Experiencing moderate low back pain daily or almost every day for at least three months with pain rating of 3 or higher on a numeric scale
- Able to speak and read English
- No plans to change pain medication during the trial
You will not qualify if you...
- Serious illnesses such as cancer, bloodborne illnesses, low blood platelet count, or currently receiving chemotherapy
- Diagnosis of psychosis
- Physical limitations preventing meditation practice
- Previous participation in a meditation program
- No access to the internet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants practice mindfulness-based meditation or a sham meditation daily for two weeks, followed by continued meditation practice for an additional six weeks.
Visits at baseline, 2 weeks, and 8 weeks for assessments
Trial Site Locations
Total: 1 location
1
Florida State University
Tallahassee, Florida, United States, 32308
Actively Recruiting
Research Team
J
Jie Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here