Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06384001
Other study ID # STUDY00004032
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03243084 - Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Completed NCT03162952 - RAND Center of Excellence for the Study of Appropriateness of Care in CAM
Completed NCT03240146 - Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain N/A
Completed NCT05282589 - Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients N/A
Completed NCT03637998 - Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain N/A
Recruiting NCT02289170 - Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) N/A
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT02231554 - Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial N/A
Recruiting NCT02063503 - Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients N/A
Completed NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT01490905 - A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain Phase 4
Completed NCT01177241 - Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids N/A
Completed NCT01177254 - Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions N/A
Completed NCT01177280 - Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes N/A
Completed NCT00984815 - Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Phase 3
Completed NCT00761150 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00763321 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00767806 - A Study for Patient With Chronic Low Back Pain Phase 3