Stanford Center for Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-Time fMRI
CBT or MBSR
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
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.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Other
Arm Label
Project 1- Real-Time fMRI
Project 2 - CBT/MBSR
Project 3- Acupuncture
Arm Description
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
This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)
This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator
Outcomes
Primary Outcome Measures
Changes in pain severity
Visual Analogue Scale from 0 to 100, where 0=no pain and 100=worst pain imaginable
Secondary Outcome Measures
Changes in pain symptom severity and well being
Responses to NIH PROMIS measures such as Pain Interference, Pain Behavior, Physical Function, Fatigue, Sleep Disturbance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02503475
Brief Title
Stanford Center for Back Pain
Official Title
Stanford Center for Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Project 1- Real-Time fMRI
Arm Type
Other
Arm Description
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
Arm Title
Project 2 - CBT/MBSR
Arm Type
Experimental
Arm Description
This arm investigates 2 experimental groups:
Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)
Arm Title
Project 3- Acupuncture
Arm Type
Other
Arm Description
This arm investigates Acupuncture within 2 groups:
Verum- Experimental Sham- Sham comparator
Intervention Type
Other
Intervention Name(s)
Real-Time fMRI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT or MBSR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.
Primary Outcome Measure Information:
Title
Changes in pain severity
Description
Visual Analogue Scale from 0 to 100, where 0=no pain and 100=worst pain imaginable
Time Frame
Up to 12 months post-treatment
Secondary Outcome Measure Information:
Title
Changes in pain symptom severity and well being
Description
Responses to NIH PROMIS measures such as Pain Interference, Pain Behavior, Physical Function, Fatigue, Sleep Disturbance
Time Frame
Up to 12 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corinne Jung, PhD
Phone
650-724-0522
Email
cejung@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Mackey, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Gross, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Manber, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Mackey, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Jung, PhD
Phone
650-724-0522
Email
cejung@stanford.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
36166279
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.
Results Reference
derived
PubMed Identifier
30541586
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.
Results Reference
derived
Learn more about this trial
Stanford Center for Back Pain
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