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Behavioral Intervention

Meditation for Chronic Low Back Pain

N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 50 years or older
Experiencing moderate low back pain daily or almost every day for at least the previous three months (≥3 out of 10 on numeric rating scale [NRS])
Must not have
Inflammatory or malabsorptive intestinal diseases
Function limitation precluding the meditation practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 weeks and 8 weeks

Summary

This trial aims to enroll 66 older adults with chronic low back pain and study the effects of a mindfulness-based meditation program on their pain and symptoms over 8 weeks. Researchers also want to see how

Who is the study for?
This trial is for community-dwelling older adults aged 50 or above who have been experiencing moderate chronic low back pain daily or almost every day for the past three months. Participants should be able to speak and read English, not planning to change their pain medication during the study, and must have intact cognition.
What is being tested?
The trial is testing a mindfulness-based meditation (MBM) program against a sham MBM intervention to see if it can reduce pain in older adults with chronic low back pain. It also examines how MBM affects the Gut-Brain Axis over an 8-week period.
What are the potential side effects?
Since this trial involves meditation interventions, there are no direct physical side effects expected from participating. However, participants may experience emotional discomfort or increased awareness of existing pain during meditation sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.
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I have had moderate low back pain almost daily for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes inflammation or poor absorption in my intestines.
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I cannot perform meditation due to physical limitations.
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I do not have any serious illnesses like cancer, blood diseases, low platelets, or a history of chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2 weeks and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 weeks and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pain intensity and interference
Secondary study objectives
Chang in inflammatory cytokines
Change in anxiety
Change in chronic pain self-efficacy
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active MBMExperimental Treatment1 Intervention
The active MBM is designed to be applied for 20 minutes per session daily.
Group II: Sham MBMPlacebo Group1 Intervention
The sham MBM intervention matches the active MBM

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,575 Total Patients Enrolled
~44 spots leftby Oct 2025
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