Stanford Center for Back Pain
NCT02503475 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2024-09-27
Summary
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.
Conditions
- Chronic Low Back Pain
Interventions
- OTHER
-
Real-Time fMRI
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.
- BEHAVIORAL
-
CBT or MBSR
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.
- DEVICE
-
Acupuncture
Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Sean Mackey, MD, PhD · Stanford University
-
James Gross, PhD · Stanford University
-
Rachel Manber, PhD · Stanford University
-
Sean Mackey, MD, PhD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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