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

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

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 Mind Body Therapy for Chronic Pain?

Research on mindfulness-based interventions (MBI) shows they are effective for chronic musculoskeletal pain, which is similar to chronic pain conditions targeted by Mind Body Therapy. Additionally, neurostimulation techniques like transcranial magnetic stimulation (TMS) have been shown to reduce pain intensity in chronic myofascial pain syndrome, suggesting potential benefits for similar chronic pain conditions. ^{1 2 3 4 5}

How does Mind Body Intervention 1 differ from other treatments for chronic pain?

Mind Body Intervention 1 is unique because it focuses on the mind-body connection to address chronic pain, using techniques like mindfulness, meditation, and stress reduction, which can help reduce pain intensity with minimal side effects, unlike traditional drug therapies that may have significant side effects. ^{1 3 4 6 7}

Research Team

Michael W Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Mindfulness and Chronic Musculoskeletal Pain: An Umbrella Review. [2023]

2. United States 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. [2022]

3. Switzerland 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. [2022]

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

Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. [2022]

5. United States 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. [2022]

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

Cognitive and emotional control of pain and its disruption in chronic pain. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Mind-body medicine in pain management]. [2023]