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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Mindfulness-based Stress Reduction (MBSR) can help manage chronic pain. Researchers aim to determine if MBSR works differently based on individuals' unique pain experiences. Those experiencing long-lasting, non-cancer-related pain might be suitable for this study. Participants should be able to speak and write in English. As an unphased trial, this study offers a unique opportunity to contribute to understanding how MBSR can be tailored to individual pain experiences.

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 prior data suggests that Mindfulness-Based Stress Reduction is safe for managing chronic pain?

Previous studies have shown promise for Mindfulness-Based Stress Reduction (MBSR) in helping people with chronic pain. Research suggests that MBSR might reduce pain and improve mental health issues like stress.

A review of studies found that mindfulness meditation, a component of MBSR, can slightly reduce pain, indicating MBSR's potential benefit for those with chronic pain. Another review found that online mindfulness programs, similar to MBSR, were more effective than usual care in relieving pain.

Importantly, MBSR has been used in various settings and is generally well-tolerated. Studies have not reported any major safety concerns, making it a potentially safe option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic pain, which often rely on medications like opioids or NSAIDs, Mindfulness-Based Stress Reduction (MBSR) offers a unique, non-pharmacological approach. MBSR is designed to reduce pain through mindfulness, meditation, and yoga techniques, which can help individuals manage pain by enhancing their awareness and acceptance of the present moment. Researchers are excited about MBSR because it has the potential to reduce reliance on medications and their associated side effects, offering a holistic and sustainable method for managing chronic pain.

What evidence suggests that MBSR is effective for managing chronic pain?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), which participants in this trial will receive, can help individuals with long-term pain. One study found that MBSR programs might lower pain levels within 13 months for those with chronic pain. Another study demonstrated that MBSR improved back pain and movement limitations more than usual care after 26 weeks. Additionally, a clinical trial found that MBSR reduced both pain levels and the distress caused by pain. These findings suggest that MBSR can effectively manage chronic pain symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Todd Favorite, Ph.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514835/

Mindfulness-Based Stress Reduction (MBSR) for Chronic ... Primary outcome measures included: (1) knowledge and awareness of MBSR (12-items); (2) confidence in seeking out MBSR for pain (5-items); (3) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904225001225

Effect of Mindfulness-Based Stress Reduction on Patients ... The results of this RCT indicate that MBSR programs may play a positive role in improving intensity of pain, within 13 months for patients with chronic pain.

3. 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.

4. link.springer.com link.springer.com/article/10.1007/s12671-022-02023-1

Mindfulness-Based Pain Management (MBPM) for Chronic ... Mindfulness-based pain management (MBPM) has evidenced significant positive changes in patients with chronic pain, but so far, no RCT study has been conducted.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21753729/

Comparing the effectiveness of mindfulness-based stress ... This randomized, clinical trial showed that both MBSR and MPI programs reduced pain intensity and pain-related distress although no statistically significant ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022399913003760

A systematic review and meta-analysis of mindfulness ... Systematic reviews have already shown that MBSR might be effective for chronic pain conditions [10], [11], [12] and for mental problems such as stress, ...

7. academic.oup.com academic.oup.com/abm/article/51/2/199/4564147

Mindfulness Meditation for Chronic Pain: Systematic Review ... We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs.

8. hsrd.research.va.gov hsrd.research.va.gov/impacts/mbi-pain.cfm

Telehealth Mindfulness-Based Interventions (MBIs) for ... Two versions of a telehealth mindfulness-based intervention (MBI) are each more effective than usual care in relieving chronic pain.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00106275

Mindfulness-Based Stress Reduction Program as an ... MBSR will be proven to be a reliable and efficacious treatment for fibromyalgia as reflected in an improvement in patient reported health variables.