Meditation for Older Adults With Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Mindfulness-based Meditation for Older Adults With Chronic Low Back Pain Based on the Gut-brain Axis: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384001
• Other study ID #: STUDY00004032
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Florida State University
• Contact: Jie Chen
• Phone: (850) 645-0657
• Email: jc22db[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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), and inflammatory cytokines (CRP, IL and TNF).

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. We also hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly decreased inflammatory cytokines (CRP, IL and TNF) levels at 8-weeks follow up than older adults randomized to the sham mindfulness-based meditation group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain sensitivities	Quantitative sensory testing (QST) will be used to measure sensitivity to experimental pain with standardized stimuli to test both nociceptive and non-nociceptive systems.	Baseline and 2 weeks and 8 weeks
Secondary	Change in pain modulation	Conditioned pain modulation (CPM) will also be measured. The CPM effect will be calculated as the pressure pain threshold difference between the rating at the initiation and the rating at the 60 seconds of the cold stimuli.	Baseline and 2 weeks and 8 weeks
Secondary	Change in chronic pain self-efficacy	Chronic Pain Self-Efficacy Scale (CPSES) will be used to measure pain self-efficacy with scores from 0-100, higher scores indicating improved self-efficacy.	Baseline and 2 weeks and 8 weeks
Secondary	Change in anxiety	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring anxiety. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 2 weeks and 8 weeks
Secondary	Change in cognitive complaints	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring cognitive complaints. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 2 weeks and 8 weeks
Secondary	Change in depression	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring depression. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 2 weeks and 8 weeks
Secondary	Change in fatigue	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring fatigue. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 2 weeks and 8 weeks
Secondary	Change in sleep disturbance	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring sleep disturbance. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 2 weeks and 8 weeks
Secondary	Change in pain-related cortical response	Cortical activity associated with pain stimuli will be assessed utilizing a continuous-wave, multichannel functional near-infrared spectroscopy (fNIRS) imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) equipped with three semiconductor lasers emitting at 780, 805, and 830 nm. Optical data will be gathered while subjects undergo thermal pain stimulation.	Baseline and 2 weeks and 8 weeks
Secondary	Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut	The 16S rRNA V4 region will be amplified and sequenced by using stool samples to depict the fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut.	Baseline and 8 weeks
Secondary	Chang in inflammatory cytokines	The inflammatory cytokines, including CRP, IL, and TNF, will assayed. The assay and analysis will follow the manufacturer's protocol.	Baseline and 8 weeks