Meditation for Older Adults With Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active MBM, Sham MBM.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 50 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial
Overview
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).
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.
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 - 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]
Secondary outcome measures (9)
- Change in pain sensitivities [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in pain modulation [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in chronic pain self-efficacy [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in anxiety [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in depression [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in fatigue [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in sleep disturbance [Time frame: Baseline and 2 weeks and 8 weeks]
- Change in pain-related cortical response [Time frame: Baseline and 2 weeks and 8 weeks]
- Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut [Time frame: Baseline and 2 weeks and 8 weeks]
Eligibility criteria
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)
- psychosis
- function limitation precluded the meditation practice
- participated meditation program before
- no access to the internet
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Florida State University — Tallahassee
Identifiers
NCT: NCT06384001 · STUDY00004032