NCT06384001 · Florida State University
Meditation for Older Adults With Chronic Low Back Pain
What this study is about
This pilot randomly assigned controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks.
View original scientific description
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).
Interventions
BEHAVIORAL
Active MBM
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).
BEHAVIORAL
Sham MBM
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.
Primary outcome measures
Change in pain intensity and interference
Time frame: Baseline and 2 weeks and 8 weeks
Pain Inventory (BPI) will be used to assess the multidimensional aspects of pain, its location, intensity, and interference. A higher score indicated higher pain intensity with 0 indicating no pain and 10 indicating the worst pain. A higher score of pain interference means daily functions are more impacted by pain, and 0 indicates no pain interference, and 10 means the worst pain interference.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- aged 50 years older
- intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
- experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
- able to speak and read English
- not intent to change medication regimens for pain throughout the trial
Exclusion criteria
- serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy)
- function limitation precluded the meditation practice
- participated meditation program before
- no access to the internet
Where
- Tallahassee, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations