Meditation for Older Adults With Chronic Low Back Pain

NCT06384001 | Recruiting

• 1 other identifier: STUDY00004032
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Low Back Pain

Keywords

Mindfulness; Older adults

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity and interference

  Pain Inventory (BPI) will be used to assess the multidimensional aspects of pain, its location, intensity, and interference. A higher score indicated higher pain intensity with 0 indicating no pain and 10 indicating the worst pain. A higher score of pain interference means daily functions are more impacted by pain, and 0 indicates no pain interference, and 10 means the worst pain interference.

  Baseline and 2 weeks and 8 weeks

Secondary Outcomes (9)

• Change in pain sensitivities

  Baseline and 2 weeks and 8 weeks

• Change in pain modulation

  Baseline and 2 weeks and 8 weeks

• Change in chronic pain self-efficacy

  Baseline and 2 weeks and 8 weeks

• Change in anxiety

  Baseline and 2 weeks and 8 weeks

• Change in depression

  Baseline and 2 weeks and 8 weeks

Study Arms (2)

Active MBM

EXPERIMENTAL

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

Behavioral: Active MBM

Sham MBM

SHAM COMPARATOR

The sham MBM intervention matches the active MBM

Behavioral: Sham MBM

Interventions

Active MBM BEHAVIORAL

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 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).

Active MBM

Sham MBM BEHAVIORAL

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.

Sham MBM

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32308, United States

RECRUITING

Central Study Contacts

Jie Chen

CONTACT

(850) 645-0657; jc22db@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 25, 2024
• Study Start: September 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)