Meditation for Chronic Low Back Pain

Overseen By Jie Chen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cancer, Chronic pain, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

66 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your current medication regimen for pain throughout the study.

What data supports the effectiveness of this treatment for chronic low back pain?

Research shows that mindfulness-based stress reduction (MBSR) can help improve pain levels and quality of life for people with chronic low back pain. Studies have found that MBSR, which involves meditation and mindfulness practices, can be a useful addition to or replacement for traditional pain treatments. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and is recommended as a first-line non-drug treatment for chronic low back pain by the American College of Physicians. ^{1 2 3 6 7}

How is the treatment Mindfulness-Based Meditation (MBM) different from other treatments for chronic low back pain?

Mindfulness-Based Meditation (MBM), also known as Mindfulness-Based Stress Reduction (MBSR), is unique because it is a non-drug approach that focuses on improving mental health and quality of life through mindfulness practices, which can complement or replace traditional pain medications. It involves a structured program of meditation and mindfulness exercises, making it an appealing option for those interested in a holistic approach to managing chronic low back pain. ^{1 2 5 6 7}

What is the purpose of this trial?

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).

Eligibility Criteria

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.

Inclusion Criteria

Intact cognition (examined by the Mini-Mental State Exam, score ≥ 24)

Able to speak and read English

Not intending to change medication regimens for pain throughout the trial

Exclusion Criteria

I have a condition that causes inflammation or poor absorption in my intestines.

I have chronic pain conditions like arthritis or headaches.

Psychosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mindfulness-based meditation (MBM) intervention for 20 minutes per session daily

8 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Active MBM
• Sham MBM

Trial Overview 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.

Participant Groups

Group I: Active MBM Experimental Treatment 1 Intervention

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

Group II: Sham MBM Placebo Group 1 Intervention

The sham MBM intervention matches the active MBM

Active MBM is already approved in United States for the following indications:

Approved in United States as Mindfulness-Based Meditation for:

• Chronic Low Back Pain

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Findings from Research

Mindfulness-based stress reduction (MBSR) techniques significantly improve subjective pain scores and quality of life in chronic pain patients, particularly those with chronic low back pain, based on a review of 12 empirical studies.

Despite some limitations such as small sample sizes and varied pain measurement tools, the evidence suggests that MBSR can be an effective non-pharmacological treatment option for managing chronic pain and enhancing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. Smith, SL., Langen, WH.[2022]

In a study of 342 adults with chronic low back pain, mindfulness-based stress reduction (MBSR) showed a significant improvement in functional limitations and pain bothersomeness compared to usual care, with 60.5% of MBSR participants reporting meaningful improvement at 26 weeks.

MBSR was found to be equally effective as cognitive behavioral therapy (CBT) in improving outcomes, suggesting that both therapies are viable options for managing chronic low back pain without significant differences in effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. Cherkin, DC., Sherman, KJ., Balderson, BH., et al.[2022]

Mindfulness-based stress reduction (MBSR) significantly reduced pain severity in female patients with nonspecific chronic low back pain (NSCLBP) compared to those receiving usual medical care, as shown in a study of 88 patients.

MBSR also improved both physical and mental quality of life for these patients, indicating its effectiveness as a mind-body intervention for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness meditation on pain and quality of life of patients with chronic low back pain. Banth, S., Ardebil, MD.[2020]

The 8-week mindfulness-based stress reduction (MBSR) program showed medium-sized improvements in health-related quality of life, psychological functioning, and pain perception among 22 patients with chronic low back pain, indicating its potential effectiveness as a treatment.

Despite the positive outcomes in psychological and quality of life measures, EEG analyses did not show significant changes in thalamocortical dysrhythmia, suggesting that while MBSR is feasible and beneficial, further research is needed to understand its specific effects on brain activity related to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Stress Reduction (MBSR) as Treatment for Chronic Back Pain - an Observational Study with Assessment of Thalamocortical Dysrhythmia. Schmidt, S., Gmeiner, S., Schultz, C., et al.[2015]

A systematic review of three randomized controlled trials involving 117 patients with chronic low back pain found that mindfulness-based stress reduction (MBSR) showed significant short-term improvements in pain intensity and disability for patients with failed back surgery syndrome, but not for older adults with chronic low back pain.

Overall, the evidence for MBSR's effectiveness in improving pain intensity or disability in chronic low back pain is inconclusive, although there is some indication that it may help improve pain acceptance. Further research with larger sample sizes and better control conditions is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for low back pain. A systematic review. Cramer, H., Haller, H., Lauche, R., et al.[2021]

A survey of 118 primary care providers (PCPs) revealed that 70.1% were familiar with Mindfulness-Based Stress Reduction (MBSR), and 59.0% referred patients to MBSR at least once a year, indicating a significant awareness and utilization of this non-pharmacological treatment for chronic low back pain.

Collaboration between PCPs and mindfulness instructors was limited, with only 16.3% of referring PCPs reporting such collaboration, suggesting a need for improved communication and education to enhance patient access to MBSR programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. Binda, DD., Weinberg, JM., Nguyen, T., et al.[2023]

A survey of 457 adults with chronic low-back pain showed that many respondents expressed a strong interest in mindfulness-based stress reduction (MBSR) as a treatment option, indicating its potential appeal as a therapy.

Participants reported a willingness to dedicate around 3 hours per week to learn and practice MBSR techniques, aligning with the time commitment required in traditional MBSR courses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients. Sherman, KJ., Wellman, RD., Jones, SMW., et al.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness meditation on pain and quality of life of patients with chronic low back pain. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based Stress Reduction (MBSR) as Treatment for Chronic Back Pain - an Observational Study with Assessment of Thalamocortical Dysrhythmia. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for low back pain. A systematic review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients. [2023]