Clinical trial NCT02503475: Stanford Center for Back Pain
Official title: Stanford Center for Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* English Fluency
* Chronic Low Back Pain as defined by NIH task-force or Healthy Controls

Exclusion Criteria:

* MRI contraindications
* Pregnant or planning to become pregnant
* Medical conditions that would interfere with study procedures, at the discretion of the study team
* Neurologic disorder, history of seizures, stroke, or brain abnormalities, which would interfere with brain integrity, at the discretion of the study team.
* Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team.
* Other project specific criteria may apply.

Primary outcomes:
measure: Changes in pain severity
timeFrame: Up to 12 months post-treatment
Secondary outcomes:
measure: Changes in pain symptom severity and well being
timeFrame: Up to 12 months post-treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: James Gross, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Rachel Manber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Sean Mackey, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Mackey S, Gilam G, Darnall B, Goldin P, Kong JT, Law C, Heirich M, Karayannis N, Kao MC, Tian L, Manber R, Gross J. Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials. JMIR Res Protoc. 2022 Sep 27;11(9):e37823. doi: 10.2196/37823.
citation: Kong JT, MacIsaac B, Cogan R, Ng A, Law CSW, Helms J, Schnyer R, Karayannis NV, Kao MC, Tian L, Darnall BD, Gross JJ, Mackey S, Manber R. Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial. Trials. 2018 Dec 13;19(1):685. doi: 10.1186/s13063-018-3044-2.