Mind Body Therapy for Chronic Pain

Overseen By Samuel Kukler, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Organic disease, Schizophrenia, Dementia, Bipolar, 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: 4

Duration: 26 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mind-body approach can help people with chronic back pain feel better and live more comfortably. Participants will try one of two different mind-body techniques, Mind Body Intervention 1 or Mind Body Intervention 2, or continue with their usual care to determine which is most effective. The trial will also assess whether these techniques can ease anxiety related to pain and improve overall quality of life. Individuals who experience back pain at least three days a week for the past three months and are open to trying mind-body methods might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to managing chronic back pain and enhancing quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mind-body treatments for chronic pain, like those in this trial, are generally safe. Similar methods to Mind Body Intervention 1 have been studied and found effective without major safety issues. Participants often experience less pain without serious side effects.

Mind Body Intervention 2 also has research support. Studies indicate these treatments can reduce pain and improve quality of life. They are usually well-tolerated, with no major negative effects reported.

Overall, current research suggests these mind-body treatments are safe. They employ mental and physical techniques to help manage pain, which are generally low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mind-Body Interventions for chronic pain because these treatments offer a holistic alternative to standard options like medications and physical therapy. Unlike typical treatments that often rely on pharmaceuticals to manage symptoms, Mind-Body Interventions focus on teaching techniques that integrate mental and physical practices to help manage pain. This approach empowers participants to leverage their own mind-body connection, which could potentially reduce the reliance on medications and their associated side effects. Additionally, these interventions could offer a more sustainable and accessible form of pain management by teaching skills that individuals can use independently over time.

What evidence suggests that this trial's mind-body interventions could be effective for chronic back pain?

Research shows that mind-body techniques can help with chronic back pain. In this trial, participants will be assigned to different treatment arms. For those in the Mind-Body Intervention 1 arm, studies have found significant pain relief and improved movement when participants followed a program addressing both mental and physical aspects of pain. Similarly, participants in the Mind-Body Intervention 2 arm, which includes pain reprocessing therapy, have shown promising results. Specifically, one study found that about 66% of participants reported being pain-free or nearly pain-free after just four weeks. Both interventions teach techniques to reduce pain by changing how the brain processes pain signals. This approach could be a promising option for those dealing with chronic back pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael W Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic back pain, who are open to mind-body interventions. They should have moderate disability and pain intensity from their condition, experiencing pain at least three days a week for the past three months. People with severe psychiatric conditions or organic diseases causing the pain are not eligible.

Inclusion Criteria

I am open to trying mind-body therapies.

I have long-term back pain.

My back pain affects my daily activities.

Exclusion Criteria

My pain is due to a diagnosed disease like cancer or ALS, not just disc disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mind-body intervention to learn techniques for managing chronic back pain

26 weeks

Baseline, 4, 8, 13, and 26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind Body Intervention 1
• Mind body intervention 2

Trial Overview

The study tests two different mind-body interventions against usual care to see if they reduce disability and alleviate chronic back pain. It also looks at whether these methods can lessen anxiety related to the pain and improve overall quality of life.

How Is the Trial Designed?

Group I: Mind-Body Intervention 1 Experimental Treatment 1 Intervention

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.

Group II: Mind-Body Intervention 2 Active Control 1 Intervention

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.

Group III: Usual Care Active Control 1 Intervention

Participants will continue their usual care for 26 weeks

Mind Body Intervention 1 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mind Body Intervention for:

• Chronic Back Pain
• Anxiety related to pain

Approved in European Union as Mind Body Therapy for:

• Chronic Pain
• Back Pain
• Anxiety

Approved in Canada as TMS Therapy for:

• Chronic Back Pain
• Musculoskeletal Pain

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Mind-body medicine (MBM) techniques, particularly mindfulness-based stress reduction (MBSR), meditation, and yoga, can significantly lower the perception of chronic pain in individuals, offering a beneficial alternative to traditional drug therapies.

MBM, when combined with evidence-based complementary medicine, promotes self-efficacy and self-care with minimal side effects, highlighting the importance of stress reduction in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mind-body medicine in pain management]. Paul, A.[2023]

In a randomized clinical trial involving women with chronic myofascial pain syndrome, both repetitive transcranial magnetic stimulation (rTMS) and deep intramuscular stimulation therapy (DIMST) were effective in reducing pain intensity, as measured by a visual analogue scale (VAS).

The study found that while rTMS increased motor-evoked potential (MEP) amplitude, indicating a neurophysiological effect, there were no significant changes in peripheral biomarkers related to pain relief, suggesting that the analgesic effects of these techniques may not be reflected in peripheral biological measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. Medeiros, LF., Caumo, W., Dussán-Sarria, J., et al.[2022]

Mind-body therapies like meditation, yoga, and cognitive behavioral therapy may help manage chronic pain by influencing the brain's neural mechanisms related to pain modulation.

Chronic pain can change brain circuitry, making it harder to control pain over time, which highlights the importance of early intervention and the potential benefits of mind-body approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and emotional control of pain and its disruption in chronic pain. Bushnell, MC., Ceko, M., Low, LA.[2022]

Mindfulness-based interventions (MBI) show some promise in managing chronic musculoskeletal pain (CMSP), but the overall evidence is mixed due to the low quality and heterogeneity of the studies reviewed, which included 19 systematic reviews and 194 primary studies.

The variability in definitions and parameters of MBI across studies likely contributed to inconsistent results, highlighting the need for more rigorous research with standardized protocols to better assess the effectiveness of MBI for CMSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and Chronic Musculoskeletal Pain: An Umbrella Review. Cardle, P., Kumar, S., Leach, M., et al.[2023]

In a study of 33 women with chronic myofascial pain syndrome, non-responders to a pain modulation task showed increased corticospinal excitability and higher serum brain-derived neurotrophic factor (BDNF) levels compared to responders, indicating altered neurophysiological responses in chronic pain.

The findings suggest that a loss of descending pain inhibition may lead to increased central sensitization, which is associated with heightened motor cortical excitability and greater disability related to pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Framework for Understanding the Relationship between Descending Pain Modulation, Motor Corticospinal, and Neuroplasticity Regulation Systems in Chronic Myofascial Pain. Botelho, LM., Morales-Quezada, L., Rozisky, JR., et al.[2022]

In a study of 24 females with chronic myofascial pain syndrome, repetitive transcranial magnetic stimulation (rTMS) significantly reduced daily pain scores by 30.21% and decreased analgesic use by 44.56% compared to a sham treatment.

rTMS enhanced the corticospinal inhibitory system and increased serum levels of brain-derived neurotrophic factor (BDNF), suggesting that its analgesic effects are mediated through top-down regulation mechanisms without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation increases the corticospinal inhibition and the brain-derived neurotrophic factor in chronic myofascial pain syndrome: an explanatory double-blinded, randomized, sham-controlled trial. Dall'Agnol, L., Medeiros, LF., Torres, IL., et al.[2022]

In a study involving 21 patients with myofascial pain syndrome (MPS), transcranial direct-current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) showed significant additional pain reduction effects when combined with trigger-point injection (TPI).

The results indicated that after just two sessions of tDCS, patients experienced a significant decrease in pain levels, suggesting that tDCS can effectively modulate the central pain pathways and enhance the efficacy of TPI in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional effects of transcranial direct-current stimulation and trigger-point injection for treatment of myofascial pain syndrome: a pilot study with randomized, single-blinded trial. Choi, YH., Jung, SJ., Lee, CH., et al.[2022]

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Mind Body Therapy for the Treatment of Chronic Pain

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