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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different therapies can alleviate chronic low back pain and understand their mechanisms. Participants will try one of four methods: real-time brain feedback using fMRI (Real-Time fMRI Neurofeedback), mindfulness techniques to reduce stress (Mindfulness-Based Stress Reduction), cognitive behavioral therapy to change pain-related thoughts and behaviors, or acupuncture (Acupuncture Treatment). Individuals who have experienced chronic low back pain for an extended period and speak English fluently may be suitable for this study. As an unphased study, this trial offers a unique opportunity to explore innovative treatments and contribute to advancing pain management research.

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.

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

Previous studies found real-time fMRI neurofeedback to be safe, with no major side effects reported. Research on acupuncture for chronic low back pain shows it is generally safe and well-tolerated, with few side effects. Studies indicate that cognitive behavioral therapy (CBT) safely manages chronic back pain, yielding positive results without major safety concerns. Mindfulness-based stress reduction (MBSR) is also considered safe, with research suggesting it reduces pain without serious side effects. Overall, existing research supports the strong safety records of the treatments under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic back pain because they offer a fresh approach compared to traditional options like medication or surgery. Real-Time fMRI Neurofeedback is groundbreaking because it allows patients to see and potentially control their brain activity in real-time, which could lead to better pain management. Acupuncture, while not new, is being studied in a more scientific manner to clearly distinguish its effects from placebo, which could validate its use further. Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) provide psychological tools to manage pain without relying on drugs, addressing the mind-body connection in ways that common treatments don’t. Together, these methods could offer a more holistic and personalized approach to pain management.

What evidence suggests that this trial's treatments could be effective for chronic back pain?

Research has identified several promising treatments for chronic low back pain. In this trial, participants will join different treatment arms to evaluate these therapies. One arm will investigate neurofeedback using real-time brain scans; studies have found this can help people manage their brain's pain signals, leading to less pain and a better quality of life. Another arm will focus on acupuncture, which has effectively reduced pain and improved physical function, especially in older adults. The trial will also assess Cognitive Behavioral Therapy (CBT), which often reduces pain and disability more effectively than standard treatments, and Mindfulness-Based Stress Reduction (MBSR), shown to improve back pain and physical limitations over time. Each therapy offers a unique approach to addressing chronic back pain, showing real potential for relief. ^{3 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33306198/

Acupuncture for chronic nonspecific low back pain - PubMed We found low-certainty evidence (seven trials, 1403 participants) that acupuncture may relieve pain in the immediate term (up to seven days) ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838793

Acupuncture for Chronic Low Back Pain in Older Adults In this randomized clinical trial of older adults with CLBP, acupuncture needling provided greater improvements in CLBP-related dysfunction at a ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844025015130

Comparative efficacy of acupuncture for chronic low back ... Research indicates that acupuncture significantly alleviates pain through mechanisms involving the modulation of nociceptive areas in the brain and the ...

4. kpwashingtonresearch.org kpwashingtonresearch.org/index.php/news-and-events/recent-news/news-2025/acupuncture-safe-effective-chronic-low-back-pain-older-adults

Acupuncture safe and effective for chronic low back pain in ... NIH-funded study finds that acupuncture improves pain, physical functioning for older adults with persistent low back pain.

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1372748/full

Clinical efficacy of acupuncture therapy combined with ... Acupuncture therapy combined with core muscle exercises improved pain and functional status in patients with chronic nonspecific low back pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6815416/

Acupuncture therapy for chronic low back pain We will develop a network-based registry study to evaluate the effectiveness and safety of acupuncture for the treatment of chronic low back pain.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19420954/

results of a prospective observational study with 229230 ... Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03850717

Safety of Acupuncture Treatments for Chronic Low Back ... The aim of current study is retrospectively check all information documented related to side effects or adverse effects of acupuncture during treatments of ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1357513

Acupuncture for Chronic Pain: Individual Patient Data Meta ... We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.