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

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a development study with clinical outcomes. The investigators aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction) program, which draws on intervention work and clinical experience in the investigative team to optimize a mindfulness-based intervention for individuals with chronic pain. The overall goal of this study is to ensure that the MBPR program has been carefully refined and manualized in an in-person setting before performing clinical trials comparing MBPR to MBSR (Mindfulness-Based Stress Reduction) to test whether it improves pain outcomes. This study includes a Pain Attention Task that separates insula activation during experimental heat application between different pain attention conditions.

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 data supports the effectiveness of the treatment Mindfulness Based Pain Reduction for back pain?

Research shows that mindfulness-based treatments, like Mindfulness-Based Stress Reduction (MBSR), are effective for chronic low back pain. These treatments help reduce pain severity and improve function, offering a safe alternative to medications. ^{1 2 3 4 5}

Is mindfulness-based pain reduction safe for humans?

Mindfulness-based interventions, like mindfulness-based stress reduction (MBSR), have an excellent safety profile and are generally considered safe for treating chronic low back pain. ^{1 3 4 5 6}

How does Mindfulness-Based Pain Reduction differ from other treatments for back pain?

Mindfulness-Based Pain Reduction is unique because it focuses on using mindfulness techniques to help manage back pain, which can complement or replace traditional drug treatments. This approach involves practices like meditation and body awareness to improve pain management and overall quality of life without relying on medication. ^{3 6 7 8 9}

Research Team

Wolf E Mehling, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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-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]

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]

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 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]

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]

References

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

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. [2022]

3. 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]

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

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis. [2023]

5. 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]

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. England pubmed.ncbi.nlm.nih.gov

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

8. 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]

9. India pubmed.ncbi.nlm.nih.gov

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