Multimodal Therapies for Chronic Back Pain

Overseen By Corinne Jung, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurologic disorder, Seizures, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the Stanford Center for Back Pain is to investigate and characterize the mechanisms of four treatments for chronic low back pain. These interventions (research treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction, cognitive behavioral therapy, and acupuncture treatment. The investigators plan to characterize both mechanisms of treatment effects and efficacy.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the effectiveness of the treatment Multimodal Therapies for Chronic Back Pain?

Research shows that cognitive functional therapy (CFT) and mindfulness-based therapies (MBT), which are part of the multimodal approach, can reduce pain and disability in people with chronic low back pain. Mindfulness-Based Stress Reduction (MBSR) has been found to decrease long-term pain and improve short-term function in older adults with chronic low back pain. ^{1 2 3 4 5}

Is multimodal therapy for chronic back pain safe for humans?

Mindfulness-based therapies and cognitive behavioral therapies are generally considered safe for managing chronic back pain, as they focus on mental and behavioral strategies rather than medications, which can have harmful side effects. ^{1 2 3 6 7}

How does the treatment for chronic back pain differ from other treatments?

This treatment is unique because it combines multiple approaches like acupuncture, cognitive behavioral therapy, mindfulness, and real-time fMRI neurofeedback, which together target both the mind and body to manage chronic back pain. Unlike standard treatments, it focuses on changing brain activity patterns and psychological factors that influence pain perception, potentially offering a more comprehensive and effective approach. ^{2 8 9 10 11}

Research Team

Sean Mackey, MD, PhD

Principal Investigator

Stanford University

James Gross, PhD

Principal Investigator

Stanford University

Rachel Manber, PhD

Principal Investigator

Stanford University

Sean Mackey, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for English-speaking adults with chronic low back pain as defined by the NIH task force. It's not suitable for those who can't have an MRI, are pregnant or planning to become pregnant, have certain medical conditions, neurological disorders like seizures or stroke, or mental health conditions that could affect participation.

Inclusion Criteria

I have chronic low back pain or I am healthy without back pain.

English Fluency

Exclusion Criteria

Other project specific criteria may apply.

Pregnant or planning to become pregnant

MRI contraindications

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four CAM interventions: real-time fMRI neurofeedback, mindfulness based stress reduction, cognitive behavioral therapy, or acupuncture treatment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Acupuncture Treatment
• Cognitive Behavioral Therapy
• Mindfulness Based Stress Reduction
• Real-Time fMRI Neurofeedback

Trial Overview The Stanford Center for Back Pain is testing four treatments: real-time fMRI neurofeedback (brain activity feedback), mindfulness-based stress reduction (MBSR), cognitive behavioral therapy (CBT), and acupuncture to understand how they work and their effectiveness in treating chronic lower back pain.

Participant Groups

Group I: Project 3- Acupuncture Experimental Treatment 1 Intervention

This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator

Group II: Project 2 - CBT/MBSR Experimental Treatment 1 Intervention

This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)

Group III: Project 1- Real-Time fMRI Experimental Treatment 1 Intervention

This arm investigates Real-Time fMRI within 4 groups: Attention Regulation (AR) Group- Experimental Cognitive Regulation (CR) Group- Experimental Sham Group- Sham Comparator Free Strategy Group- Active Comparator

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

This study will be the largest randomized controlled trial comparing cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) in adults with chronic low back pain (CLBP) who are treated with long-term opioids, involving 766 participants.

The trial aims to evaluate the effectiveness of CBT and MBT in reducing pain intensity and improving function over 12 months, potentially offering safer alternatives to opioid therapy and enhancing quality of life for patients with CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial. Zgierska, AE., Burzinski, CA., Garland, EL., et al.[2022]

A systematic review of 20 studies on brief mindfulness-based interventions (BMBIs) suggests that they may be effective for managing acute pain, especially when delivered by a provider and lasting more than 5 minutes.

However, the overall evidence is limited and inconclusive, indicating that more rigorous and larger-scale studies are necessary before BMBIs can be recommended as a primary treatment for chronic or acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. McClintock, AS., McCarrick, SM., Garland, EL., et al.[2023]

A study involving 57 adults with chronic low back pain found that psychological treatments like cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy significantly reduced theta and alpha brain wave activity, indicating changes in brain function associated with pain management.

All treatments led to a reduction in beta power across multiple brain regions, with a specific link between reduced beta power in the central region and decreased pain intensity observed only in mindfulness-based cognitive therapy, suggesting that these psychological approaches can effectively alter brain activity related to pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Brain Oscillations as a Mechanism of Mindfulness-Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. Day, MA., Matthews, N., Mattingley, JB., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of mindfulness-based mind-body therapies in patients with non-specific low back pain-A network meta-analysis of randomized controlled trials. [2023]

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

Patient Perspectives on Participation in Cognitive Functional Therapy for Chronic Low Back Pain. [2022]

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

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial. [2022]

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

Not Just Mind Over Matter: Reviewing With Patients How Mindfulness Relieves Chronic Low Back Pain. [2020]

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

A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial. [2023]

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

Brain and behavior changes associated with an abbreviated 4-week mindfulness-based stress reduction course in back pain patients. [2021]

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

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Change in Brain Oscillations as a Mechanism of Mindfulness-Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. [2022]

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

Mind-body therapies for the management of pain. [2022]

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

Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Psychological Approaches for the Integrative Care of Chronic Low Back Pain: A Systematic Review and Metanalysis. [2022]