Stanford Center for Back Pain

• ClinicalTrials.gov Identifier: NCT02503475
• Recruitment Status: Recruiting
• First Posted: July 21, 2015
• Last Update Posted: September 23, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Sean Mackey, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Other: Real-Time fMRI; Behavioral: CBT or MBSR; Device: Acupuncture	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stanford Center for Back Pain
• Study Start Date: March 2015
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: October 2022

Arms and Interventions

Arm	Intervention/treatment
Project 1- 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	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.
Experimental: Project 2 - CBT/MBSR; This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)	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.
Project 3- Acupuncture; This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator	Device: Acupuncture; Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.

Outcome Measures

Primary Outcome Measures :

1. Changes in pain severity [ Time Frame: 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 :

1. Changes in pain symptom severity and well being [ Time Frame: Up to 12 months post-treatment ]
   Responses to NIH PROMIS measures such as Pain Interference, Pain Behavior, Physical Function, Fatigue, Sleep Disturbance

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Corinne Jung, PhD; 650-724-0522; cejung@stanford.edu

Locations

United States, California

Stanford University; Recruiting

Palo Alto, California, United States, 94304

Contact: Corinne Jung, PhD 650-724-0522 cejung@stanford.edu

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Sean Mackey, MD, PhD; Stanford University
• Principal Investigator: James Gross, PhD; Stanford University
• Principal Investigator: Rachel Manber, PhD; Stanford University
• Study Director: Sean Mackey, MD, PhD; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Sean Mackey, Redlich Professor Departments of Anesthesiology, Perioperative and Pain Medicine | Neurosciences | Neurology (by courtesy), Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab (SNAPL), Stanford University, Stanford University
• ClinicalTrials.gov Identifier: NCT02503475
• Other Study ID Numbers: 22436
• First Posted: July 21, 2015
• Last Update Posted: September 23, 2021
• Last Verified: September 2021

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations