Meditation for Older Adults With Chronic Low Back Pain

Florida State University

Status: Enrolling

Conditions: Chronic Low Back Pain

Treatments: Behavioral: Active MBM; Behavioral: Sham MBM

Study type: Interventional

Funder types: Other

Identifiers

NCT06384001

STUDY00004032

Details and patient eligibility

About

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).

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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. psychosis
3. function limitation precluded the meditation practice
4. participated meditation program before
5. no access to the internet

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Active MBM

Experimental group

Description:

The active MBM is designed to be applied for 20 minutes per session daily.

Treatment:

Behavioral: Active MBM

Sham MBM

Sham Comparator group

Description:

The sham MBM intervention matches the active MBM

Treatment:

Behavioral: Sham MBM