Clinical trial NCT06384001: Meditation for Older Adults With Chronic Low Back Pain
Official title: Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Mindfulness
Older adults
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

1. aged 50 years older
2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
4. able to speak and read English
5. not intent to change medication regimens for pain throughout the trial

Exclusion Criteria:

1. serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy)
2. other concurrent chronic pain conditions (e.g., arthritis, headache, irritable bowel syndrome)
3. psychosis
4. inflammatory or malabsorptive intestinal diseases
5. function limitation precluded the meditation practice
6. participated meditation program before
7. no access to the internet

Primary outcomes:
measure: Change in pain intensity and interference
timeFrame: Baseline and 2 weeks and 8 weeks
Secondary outcomes:
measure: Change in pain sensitivities
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in pain modulation
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in chronic pain self-efficacy
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in anxiety
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in cognitive complaints
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in depression
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in fatigue
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in sleep disturbance
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Change in pain-related cortical response
timeFrame: Baseline and 2 weeks and 8 weeks
measure: Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut
timeFrame: Baseline and 2 weeks and 8 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: