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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how mindfulness meditation can reduce pain for individuals with chronic low back pain who also use opioids. Researchers aim to understand how meditation affects the brain to relieve pain. Participants will either continue their usual care or attend sessions to learn meditation techniques for pain management. Individuals who have experienced back pain on most days for at least six months and currently use prescription opioids may be suitable for this study. As an unphased trial, this study offers participants the chance to explore innovative pain management techniques that could improve their quality of life.

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 prior data suggests that this meditation-based intervention is safe for chronic low back pain?

Research shows that mindfulness meditation is generally safe and well-tolerated by people with chronic low back pain. Studies have found that this type of meditation can improve pain and function compared to usual care. Few reports of serious side effects link to mindfulness meditation. Participants typically do not experience significant unwanted effects, making it a safe option for many. This information comes from past research, not the current trial. Always consult your doctor before joining a trial to ensure it is suitable for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic low back pain, like medications and physical therapy, focus on managing symptoms or improving physical function. But meditation offers a different approach by targeting the mind-body connection to help individuals cope with pain. Researchers are excited about meditation because it empowers patients to take an active role in their pain management through mindfulness and relaxation techniques. This approach may reduce reliance on medications and their potential side effects, offering a holistic and sustainable way to manage chronic pain.

What evidence suggests that meditation might be an effective treatment for chronic low back pain?

Research has shown that mindfulness meditation, which participants in this trial may receive, can help reduce chronic low back pain. Studies have found that mindfulness-based stress reduction (MBSR) leads to noticeable improvements in back pain and daily activities compared to regular care. For instance, one study found that people practicing MBSR reported less pain and better movement after 26 weeks. Another study suggested that mindfulness meditation not only eases pain but also boosts overall well-being. These findings indicate that mindfulness meditation could serve as a lasting treatment option for chronic low back pain. ^{2 3 4 6 7}

Who Is on the Research Team?

Eric Garland, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

My back pain is 3 or more on a scale of 0-10, even with opioid medication.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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