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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness-based meditation (MBM) can reduce pain and symptoms in older adults with chronic low back pain. It also examines how meditation might influence the gut-brain connection, which is the communication between the stomach and brain. Participants will engage in either active meditation (Active MBM) or a similar, non-active version (Sham MBM) to determine any differences. This trial targets individuals aged 50 and older who have experienced moderate back pain almost daily for the past three months and can read and speak English. Participants should also be comfortable using the internet and not plan to change their pain medication during the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research on non-drug pain management strategies.

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 prior data suggests that this mindfulness-based meditation is safe for older adults with chronic low back pain?

Research has shown that mindfulness-based meditation (MBM) is generally safe for most people. In several studies, MBM not only reduced pain but also raised few safety concerns. For example, one study found short-term improvements in pain and back-related issues with MBM while assessing safety. Other research suggests that mindfulness-based stress reduction is recommended for chronic low back pain and is well-tolerated. These studies reported no major negative effects, supporting the idea that MBM is a safe option for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Meditation-Based Modality (MBM) for chronic low back pain because it offers a non-drug alternative to traditional treatments like pain medications and physical therapy. Unlike these standard options, which often focus on symptom relief, MBM aims to address pain through mindfulness and meditation techniques, potentially reducing pain perception itself. This approach not only minimizes the risks associated with long-term medication use but also empowers patients to actively engage in their pain management, offering a holistic and sustainable solution.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

This trial will compare Active MBM with Sham MBM for managing chronic low back pain. Research has shown that mindfulness-based meditation (MBM) can reduce pain and improve the quality of life for individuals with chronic low back pain. Studies have found that MBM significantly lessens pain severity, making discomfort easier to manage. For example, one study discovered that a similar practice, mindfulness-based stress reduction (MBSR), led to a noticeable decrease in pain intensity compared to standard care. Additionally, MBM has been associated with better physical function and reduced pain over both short and long periods. These findings suggest that MBM could be a promising way to manage chronic low back pain. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Psychosis

Participation in a meditation program before

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4479890/

Effectiveness of mindfulness meditation on pain and quality ... MBSR as a mind-body therapy including body scan, sitting and walking meditation was effective intervention on reduction of pain severity.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2504811

Effect of Mindfulness-Based Stress Reduction vs Cognitive ... Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388122000913

The effectiveness of mindfulness-based stress reduction ... MBSR therapy improves physical function at 8 weeks and 6 months follow-up in CLBP individuals. Further high-quality RCTs are warranted for the long-term effect.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28437793/

Mindfulness-Based Stress Reduction for Treating Low ... Compared with usual care, MBSR was associated with short-term improvements in pain intensity (4 RCTs; mean difference [MD], -0.96 point on a ...

5. brieflands.com brieflands.com/journals/ijpbs/articles/102509

Effectiveness of Mindfulness-Based Interventions on Pain ... Effectiveness of Mindfulness-Based Interventions on Pain Intensity in Patients with Chronic Low Back Pain: A Systematic Review. Author(s):. Faeze ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06106191

Integrative Mindfulness-Based Predictive Approach for ... This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers ...

7. hsrd.research.va.gov hsrd.research.va.gov/impacts/mbi-pain.cfm

Telehealth Mindfulness-Based Interventions (MBIs) for ... Two versions of a telehealth mindfulness-based intervention (MBI) are each more effective than usual care in relieving chronic pain.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3520871/

Mindfulness-based stress reduction for low back pain. A ... Data analysis. Main outcome measures were pain intensity and back-related disability. Safety was defined as secondary outcome measure. Other outcome measures ...

9. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/optimum/

Group-Based Mindfulness for Patients With Chronic Low ... Mindfulness-based stress reduction is now recommended by the American College of Physicians for initial treatment of chronic low back pain. The primary goal of ...