Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
Meditation for Older Adults With Chronic Low Back Pain
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 and inflammatory cytokines CRP IL and TNF
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 We also hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly decreased inflammatory cytokines CRP IL and TNF levels at 8-weeks follow up than older adults randomized to the sham mindfulness-based meditation group
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 and inflammatory cytokines CRP IL and TNF
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 We also hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly decreased inflammatory cytokines CRP IL and TNF levels at 8-weeks follow up than older adults randomized to the sham mindfulness-based meditation group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None