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 — BEHAVIORALThe 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 — BEHAVIORALThe 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 MBMThe active MBM is designed to be applied for 20 minutes per session daily.
- Sham Comparator: Sham MBMThe 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
- Jie Chen(850) 645-0657
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32308 | Sharon Liebrich 850-645-6887 Jie Chen (PRINCIPAL_INVESTIGATOR) |
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