Recruiting

Meditation

Sponsor:

Florida State University

Code:

NCT06384001

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Active MBM

Sham MBM

Study Details

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

Study ID

NCT06384001

Start date

Sep 24, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Active MBM

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

sham comparator: Sham MBM

The sham MBM intervention matches the active MBM

Interventions

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 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).

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 measure

  • Change in pain intensity and interference [ Time Frame: Baseline and 2 weeks and 8 weeks ]

Central Contacts and Locations

Central contacts

Jie Chen

(850) 645-0657jc22db@fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Sharon Liebrich

850-645-6887

Principal Investigator:

Jie Chen

More Information

Sponsor

Florida State University

Last update posted

Oct 22, 2025

Last verified

Aug, 2025

Keywords

  • Mindfulness
  • Older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2025-10-22.