Meditation for Chronic Low Back Pain

Overseen By Eric Garland, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioids

Disqualifiers: Cancer, Psychosis, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be using prescription opioids for at least 3 months, so it seems you may continue those.

What data supports the effectiveness of the treatment Meditation, Mindfulness-Based Stress Reduction (MBSR), Mindfulness Meditation, Cognitive Behavioral Therapy (CBT) for chronic low back pain?

Research shows that Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) are effective for managing chronic low back pain, improving pain levels, quality of life, and mental health. MBSR, in particular, has been found to help with physical function and pain bothersomeness in individuals with chronic low back pain. ^{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. ^{3 4 5 6 7}

How is the treatment of meditation for chronic low back pain different from other treatments?

Meditation, specifically 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 medication. It is recognized as a first-line treatment for chronic low back pain by the American College of Physicians, offering an accessible and structured program over eight weeks. ^{3 4 5 7 8}

Research Team

Eric Garland, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for men and women aged 18-65 who have chronic low back pain, score it at least a 3 out of 10 even with opioid medication, and have been on prescription opioids for over three months. It's not open to those with meditation training, current cancer, recent suicide attempts, psychosis or severe substance use disorder in the last six months.

Inclusion Criteria

I have been using prescription opioids for at least 3 months.

I am between 18 and 65 years old.

I have had lower back pain on most days for the last 6 months.

Exclusion Criteria

I am currently diagnosed with cancer.

I have practiced mindfulness or meditation regularly.

I can lie still on my back for up to 1.5 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mindfulness meditation-based therapy to cope with pain, consisting of 8 sessions

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Meditation

Trial Overview The study is testing how mindfulness meditation affects pain relief in patients with chronic low back pain treated with opioids. Participants will either receive this meditation-based therapy or continue their usual care while researchers study changes in their brain related to pain.

Participant Groups

Group I: Mindfulness Experimental Treatment 2 Interventions

A well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

Group II: Meditation Experimental Treatment 2 Interventions

A validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

Group III: Usual Care Active Control 1 Intervention

Patients will receive usual medical care for chronic low back pain.

Meditation is already approved in United States, European Union for the following indications:

Approved in United States as Mindfulness Meditation for:

• Chronic Low Back Pain

Approved in European Union as Mindfulness-Based Stress Reduction (MBSR) for:

• Chronic Pain Management
• Stress Reduction

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

Mindfulness-based stress reduction (MBSR) significantly improves physical function in individuals with chronic low back pain (CLBP), as shown in a systematic review of six randomized controlled trials.

Improvements in physical function were observed at both 8 weeks and 6 months follow-up, indicating that MBSR can be an effective complementary treatment for CLBP, although further high-quality studies are needed to assess its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based stress reduction intervention on physical function in individuals with chronic low back pain: Systematic review and meta-analysis of randomized controlled trials. Soundararajan, K., Prem, V., Kishen, TJ.[2022]

In a study of 297 adults with chronic low back pain, both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) were found to be effective, but the nonjudging dimension of mindfulness significantly influenced treatment outcomes, particularly in function and pain relief.

Factors such as pain control beliefs and lower anxiety levels were associated with improvement in symptoms regardless of whether patients received MBSR or CBT, indicating that these psychological factors may play a crucial role in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain. Chen, JA., Anderson, ML., Cherkin, DC., et al.[2023]

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]

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]

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 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]

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]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program was found to be as effective as a multidisciplinary pain intervention (MPI) program in reducing pain intensity and pain-related distress in patients with chronic pain, based on a study of 99 participants.

Both interventions led to statistically significant improvements in pain and mood symptoms, but the overall differences between MBSR and MPI were not significant, indicating that both approaches can be beneficial for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. Wong, SY., Chan, FW., Wong, RL., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based stress reduction intervention on physical function in individuals with chronic low back pain: Systematic review and meta-analysis of randomized controlled trials. [2022]

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

Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain. [2023]

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. 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]

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

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

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

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. [2015]