An interventional study of Real-Time fMRI and CBT or MBSR in Chronic Low Back Pain, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
The Stanford Center for Back Pain establishes a collaborative, multidisciplinary research program to investigate CAM interventions for the treatment of chronic low back pain (CLBP). The investigators' overall goal is to characterize the shared and distinct mechanisms of four CAM interventions and translate the investigators' findings to tailored and effective treatments for CLBP. CLBP is a highly prevalent and difficult-to-treat condition for which many patients seek CAM therapies. Basic science has revealed that abnormalities in central pain modulatory and emotion regulatory systems play a crucial role in CLBP. What is not clear is how CAM therapies alter the functioning of the brain systems involved in chronic pain. The Stanford Center for Back Pain aims to fill this gap by conducting 3 projects, each aiming at elucidating mechanisms underlying different CAM therapies for CLBP.
Project 1 will focus on a promising novel alternative therapy for CLBP real-time fMRI neurofeedback which trains patients to control specific neural processes that lead to improvements in pain. Project 2 will characterize the pain modulatory and emotion regulatory effects of mindfulness based stress reduction and cognitive behavioral therapy for CLBP. Project 3 will characterize psychophysical and neuroimaging based neural mechanisms underlying verum and placebo acupuncture.
The Stanford Center for Back Pain will provide optimal collaboration and synergy within a multidisciplinary framework to identify mechanisms of CAM therapies for CLBP so that they can eventually translate them into enhance clinical care of CLBP.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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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
Other: Real-Time fMRI
This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)
Behavioral: CBT or MBSR
This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator
Device: Acupuncture
Real-Time fMRI: AR, CR, Sham, and Free Strategy groups will be compared to determine the following: (1) whether a cognitive strategy improves rtfMRI neurofeedback to modulate brain activity and pain; (2) which strategy is most effective at individual and group levels at modulating brain activity and pain; and (3) whether the investigators can predict individual ability to modulate brain activity or pain using a particular strategy and applying mixed effects modeling of treatment efficacy using baseline measurements.
CBT/MBSR: The study will investigate whether CBT versus MBSR differentially enhance behavioral and neural indices of the ability to implement cognitive regulation (CR) and attention regulation (AR) during evoked pain in the lower back in participants with chronic low back pain. An additional wait list control (WL) group will be used to determine the effects of time on pain symptom severity and well-being.
Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.
Changes in pain severity
Visual Analogue Scale from 0 to 100, where 0=no pain and 100=worst pain imaginable
Time frame: Up to 12 months post-treatment
Changes in pain symptom severity and well being
Responses to NIH PROMIS measures such as Pain Interference, Pain Behavior, Physical Function, Fatigue, Sleep Disturbance
Time frame: Up to 12 months post-treatment
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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