Stanford Center for Back Pain

Not Applicable

Active, not recruiting

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: CBT or MBSR; Device: Acupuncture; Other: Real-Time fMRI

• Registration Number: NCT02503475
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project 2 - CBT/MBSR	CBT or MBSR	This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)
Project 3- Acupuncture	Acupuncture	This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator
Project 1- Real-Time fMRI	Real-Time fMRI	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

Primary Outcome Measures

Name	Time	Method
Changes in pain severity	Up to 12 months post-treatment	Visual Analogue Scale from 0 to 100, where 0=no pain and 100=worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Changes in pain symptom severity and well being	Up to 12 months post-treatment	Responses to NIH PROMIS measures such as Pain Interference, Pain Behavior, Physical Function, Fatigue, Sleep Disturbance

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States