Mindfulness-Based Therapy for Chronic Lower Back Pain

(IMPACT Trial)

Overseen By Jose Baez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Recent pain worsening, Pregnancy, Cancer, 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

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain. The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment. The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help improve pain levels and quality of life for people with chronic lower back pain. Studies have found that MBSR, which includes mindfulness meditation, can be an effective way to manage pain and enhance mental well-being. ^{1 2 3 4 5}

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

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and is recommended by the American College of Physicians as a first-line non-drug treatment for chronic low back pain. ^{1 4 5 6 7}

How is Mindfulness-Based Stress Reduction (MBSR) different from other treatments for chronic lower back pain?

Mindfulness-Based Stress Reduction (MBSR) is unique because it is a non-drug treatment that focuses on mindfulness meditation to help manage chronic lower back pain, potentially reducing the need for medication. It is an eight-week group program that emphasizes mental awareness and stress reduction, which can improve pain management and quality of life. ^{1 4 5 6 8}

Research Team

Natalia Morone, MD MS

Principal Investigator

Boston Medical Center

Jean King, PhD

Principal Investigator

Worcester Polytechnic Institute

Emmanuel Agu, PhD

Principal Investigator

Worcester Polytechnic Institute

Eligibility Criteria

This trial is for English-speaking individuals who have had chronic low back pain for at least 3 months, with pain on most days in the past 6 months. Participants must be able to consent and plan to stay at a participating clinic for over 6 months. It's not suitable for those with recent severe symptoms, unexplained weight loss or fever, pregnant women, or people with metastatic cancer.

Inclusion Criteria

Willing and able to provide online or telephone informed consent

I have had lower back pain for at least 3 months, with pain on most days in the last 6 months.

Speak English as the intervention manual is currently written in English

Exclusion Criteria

Pregnancy

I am not a patient at, nor plan to be at a participating clinic for 6+ months.

I have not experienced worsening pain, unexplained fever, or weight loss in the past month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

UG3 Phase

Machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, with recruitment and outcomes assessment with 50 persons

24 months

UH3 Phase

Biopsychosocial markers identified for cLBP response to MBSR, with data collection for training and testing ML models

6 months

Weekly group meetings via Zoom for 8 weeks, 90 minutes per session

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Mindfulness-Based Stress Reduction

Trial Overview The study tests how well mindfulness-based stress reduction (MBSR) helps chronic low back pain by using machine learning to analyze biological, psychological, and social factors. The goal is to predict individual responses to MBSR and improve treatment decisions.

Participant Groups

Group I: Mindfulness based stress reduction (MBSR) program Experimental Treatment 3 Interventions

Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.

Mindfulness-Based Stress Reduction is already approved in United States, European Union for the following indications:

Approved in United States as Mindfulness-Based Stress Reduction for:

• Chronic Low Back Pain

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Chronic Pain Management
• Stress Reduction

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Worcester Polytechnic Institute

Collaborator

Trials

19

Recruited

30,000+

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]

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 stress reduction (MBSR) significantly reduced pain severity in female patients with nonspecific chronic low back pain (NSCLBP) compared to those receiving usual medical care, as shown in a study of 88 patients.

MBSR also improved both physical and mental quality of life for these patients, indicating its effectiveness as a mind-body intervention for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness meditation on pain and quality of life of patients with chronic low back pain. Banth, S., Ardebil, MD.[2020]

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]

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]

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]

References

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

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

2. 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]

3. India pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness meditation on pain and quality of life of patients with chronic low back pain. [2020]

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

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

5. 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]

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

Characterizing Interprofessional Collaboration and Referral to Mindfulness-Based Stress Reduction Programs. [2023]

7. 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]

8. England 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. [2022]