Mindfulness-Based Pain Reduction for Back Pain

(MBPR Trial)

Overseen By Wolf E Mehling, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cancer, Liver failure, Renal failure, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an 8-week Mindfulness-Based Pain Reduction (MBPR) program to help individuals manage chronic low back pain. The goal is to determine if this mindfulness approach reduces pain more effectively than traditional Mindfulness-Based Stress Reduction (MBSR). Participants who have experienced back pain for at least half the days in the past six months and own a smartphone may be suitable for this study. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on regular opioid prescriptions, you can participate as long as your medication has been stable for the past 3 months.

What prior data suggests that this mindfulness-based program is safe for individuals with chronic pain?

In a previous study, researchers developed Mindfulness-Based Pain Reduction (MBPR) to address chronic pain. This treatment builds on Mindfulness-Based Stress Reduction (MBSR), which has been somewhat successful in reducing back pain and improving function compared to usual care.

Research has shown that mindfulness-based therapies are generally safe. They emphasize meditation and awareness, avoiding medications or physical treatments. As a result, people usually find them easy to handle. No serious side effects have been reported in studies using mindfulness for pain management. Instead, participants often experience positive changes in managing pain and stress.

In summary, mindfulness-based treatments like MBPR are typically safe and manageable. They provide a gentle approach to managing chronic pain without the risks associated with more invasive treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mindfulness-Based Pain Reduction (MBPR) technique is unique because it offers a non-drug approach to managing back pain, focusing on mental and emotional strategies rather than traditional medication. Unlike standard treatments like NSAIDs or physical therapy, MBPR harnesses mindfulness practices to help individuals manage pain through heightened awareness and cognitive techniques. Researchers are excited about MBPR because it empowers patients to take control of their pain experience, potentially reducing the need for medications and their associated side effects. This approach not only addresses the physical aspect of pain but also promotes overall mental well-being, offering a holistic alternative to conventional treatments.

What evidence suggests that Mindfulness-Based Pain Reduction could be effective for back pain?

Research has shown that mindfulness-based programs can effectively reduce pain in adults with chronic low back pain. A study that combined results from multiple research papers found that these programs significantly lower pain levels. In this trial, participants will join different groups to evaluate the effectiveness of Mindfulness-Based Pain Reduction (MBPR) and Mindfulness-Based Stress Reduction (MBSR). Mindfulness-Based Stress Reduction (MBSR), a similar method, has improved back pain and physical ability over time. Specifically, people with chronic low back pain who participated in MBSR therapy experienced better physical function at both 8 weeks and 6 months. These findings suggest that programs like MBPR could effectively manage pain. ^{3 5 6 7 8}

Who Is on the Research Team?

Wolf E Mehling, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back pain, experiencing pain on most days over the past 6 months. Participants must have a smartphone, speak English, and rate their pain at least 3 out of 10. Exclusions include severe medical conditions like spine tumors or fractures, major mental health issues, recent back injections, pregnancy-related back problems, unstable housing plans, and certain MRI contraindications.

Inclusion Criteria

You have a smartphone.

Your average pain in the last month needs to be at least a 3 out of 10 on a pain scale. If your pain is less than that, it may be too mild to see if the treatment helps.

You have had pain in your lower back for at least half of the days in the past 6 months, as shown by specific questions and a drawing of the pain area.

Exclusion Criteria

Unable to provide informed consent.

You have or had an infection, tumor, fracture, or nerve issue in your spine.

Involved in Worker's Compensation claim.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week MBPR or MBSR program with weekly 2½-hour group sessions and a daylong retreat

8 weeks

8 weekly group sessions, 1 daylong retreat

Follow-up

Participants are monitored for changes in pain intensity, pain interference, and interoceptive awareness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Based Pain Reduction

Trial Overview The study tests an 8-week Mindfulness-Based Pain Reduction (MBPR) program designed to help individuals manage chronic pain. It will be refined based on feedback before comparing it to Mindfulness-Based Stress Reduction (MBSR) in future trials. The study includes tasks measuring attention to pain during heat application.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

4 cohorts of 10 participants to MBPR (First 3 groups single-arm, final group of 10 randomly assigned to MBPR)

Group II: Group 2 Active Control 1 Intervention

The last 20 participants will be randomly assigned to MBSR or MBPR, which will results in a control group with \~10 participants undergoing MBSR

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

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]

Mindfulness and meditation significantly help older adults (aged 65 and older) cope with chronic low back pain by reducing negative emotions like fear and changing their perspective on pain, as revealed through focus group discussions with 25 participants who completed an eight-week program.

Key themes identified include overcoming fear of pain, increased awareness of pain rather than focusing on it, and a shift in how significant they perceive their pain, suggesting that mindfulness can effectively alter the emotional and cognitive responses to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. Luiggi-Hernandez, JG., Woo, J., Hamm, M., et al.[2020]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce pain intensity in adults with chronic low back pain (CLBP), based on a meta-analysis of 18 studies that utilized validated pain outcome measures.

Despite the promising results indicating a large effect size for MBIs, the findings should be interpreted cautiously due to variability in study methodologies, small sample sizes, and potential biases, highlighting the need for more robust large-scale randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis. Paschali, M., Lazaridou, A., Sadora, J., 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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37942696/

Mindfulness-based Interventions for Chronic Low Back Pain The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. Conclusions: MBIs ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT00494845

Mindfulness Meditation for Chronic Low Back Pain in Older ... The primary objective of this study is to determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in ...

5. pure.psu.edu pure.psu.edu/en/publications/mindfulness-based-interventions-for-chronic-low-back-pain-a-syste

Mindfulness-based Interventions for Chronic Low Back ... The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. Conclusions: MBIs ...

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH A 2020 analysis of 19 studies examined the effects of mindfulness-based therapies for acute pain and found no evidence of reduced pain severity.

7. va.gov va.gov/WHOLEHEALTHLIBRARY/tools/mindfulness-meditation-for-chronic-low-back-pain.asp

Mindfulness Meditation for Chronic Low Back Pain - Whole ... Mindfulness-based interventions can exert biological effects and have been associated with beneficial changes in brain areas involved in adaptive pain, stress, ...

8. dovepress.com dovepress.com/development-and-initial-validation-of-mindfulness-based-pain-reduction-peer-reviewed-fulltext-article-JPR

Development and initial validation of Mindfulness-Based ... We aimed to optimize MBSR for chronic pain by using recent research to develop Mindfulness-Based Pain Reduction (MBPR) and test it in patients with cLBP.