MBSR for Chronic Pain

Overseen By Elizabeth Banner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cancer pain, Visual, Hearing, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of this study is to better understand how Mindfulness-based Stress Reduction (MBSR) is the most helpful in terms of management of chronic pain symptoms. The studies hypothesis is that an Interventional Response Phenotyping study (light phenotyping) can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic pain disorders.

Do I need to stop my current medications for the MBSR for Chronic Pain trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Mindfulness-Based Stress Reduction (MBSR) for chronic pain?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help reduce pain intensity, improve quality of life, and enhance mental health for people with chronic pain, including those with chronic low back pain and migraines. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

The available research does not specifically address the safety of Mindfulness-Based Stress Reduction (MBSR) for chronic pain, but it is generally considered a safe, non-drug approach for managing pain and stress. ^{1 2 6 7 8}

How is the MBSR treatment different from other treatments for chronic pain?

MBSR (Mindfulness-Based Stress Reduction) is unique because it uses mindfulness meditation techniques to help manage chronic pain, which can complement or replace traditional drug treatments. Unlike medications, MBSR focuses on improving mental health and quality of life by teaching patients to be more aware of their thoughts and feelings, potentially reducing pain-related distress. ^{1 2 3 4 6}

Research Team

Todd Favorite, Ph.D.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults over 18 with various chronic pain disorders, excluding lower back pain linked to specific conditions. Participants should have experienced pain for at least six months and on most days, with significant daily life interference due to pain. Those with cancer-related pain or sensory impairments that would hinder participation are not eligible.

Inclusion Criteria

You must have a pain interference score of 60 or higher on the PROMIS Pain Interference scale.

I experience chronic pain that is not caused by my cancer.

I have a chronic pain condition that is not lower back pain.

Exclusion Criteria

I cannot speak or write in English.

I do not have severe visual or hearing problems.

I experience chronic pain due to my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of Mindfulness-based Stress Reduction (MBSR) therapy

8 weeks

Surveys completed at various time points pre-treatment and post-treatment

Follow-up

Participants are monitored for changes in pain intensity, anxiety, and pain interference

4 weeks

Surveys at 8 and 12 weeks

Treatment Details

Interventions

• MBSR treatment

Trial Overview The study aims to understand how Mindfulness-based Stress Reduction (MBSR) helps manage chronic pain symptoms in different individuals. It will explore if light phenotyping can predict who benefits most from MBSR by identifying varying underlying mechanisms of their chronic pain.

Participant Groups

Group I: MBSR treatment Experimental Treatment 1 Intervention

MBSR treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MBSR for:

• Chronic pain management
• Stress reduction
• Anxiety
• Depression

Approved in European Union as MBSR for:

• Chronic pain management
• Stress reduction
• Anxiety
• Depression

Approved in Canada as MBSR for:

• Chronic pain management
• Stress reduction
• Anxiety
• Depression

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

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 feasibility trial involving 60 patients with migraine headaches, Mindfulness-Based Stress Reduction (MBSR) was successfully implemented, with 68% of participants adhering to the intervention by attending at least 5 out of 8 classes.

Key factors for successful recruitment and retention included close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the healthcare delivery system, highlighting the importance of these strategies for future MBSR trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. Law, H., Avins, A., Stahl, R., et al.[2021]

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]

An eight-week Mindfulness-Based Stress Reduction (MBSR) program showed significant improvements in pain disability, psychological distress, and activity levels among 17 adult patients with chronic pain.

Participants reported a greater willingness to experience pain and lower subjective ratings of current pain, indicating that MBSR can be an effective intervention for managing chronic pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. Beaulac, J., Bailly, M.[2019]

Mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) both show clinically significant benefits in improving physical functioning and reducing pain intensity in patients with chronic pain, based on a review of 21 studies involving over 1,900 participants.

There was no significant difference in effectiveness between MBSR and CBT, suggesting that both therapies are viable options for managing chronic pain, but further research is needed to standardize measures and guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. Khoo, EL., Small, R., Cheng, W., 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]

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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

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

2. Scotland pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. [2021]

3. 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]

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

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients. [2023]