Stanford Center for Back Pain

NCT ID: NCT02503475

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2026-12-31

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: OTHER

Real-Time fMRI

Intervention Type: OTHER

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.

Project 2 - CBT/MBSR

This arm investigates 2 experimental groups:

Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)

Group Type: EXPERIMENTAL

CBT or MBSR

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Acupuncture

Intervention Type: DEVICE

Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Acupuncture

Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Mackey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

James Gross, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Rachel Manber, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sean Mackey, MD, PhD

Role: STUDY_DIRECTOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

References

Karayannis NV, Smuck M, Law C, Mackey SC, Gross JJ, Darnall BD, Hush J. Self-reported physical function is strongly related to pain behavior and pain interference and weakly related to physical capacity in people with chronic low back pain. Musculoskelet Sci Pract. 2023 Feb;63:102721. doi: 10.1016/j.msksp.2023.102721. Epub 2023 Jan 23.

Reference Type: DERIVED

PMID: 36759316 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36166279 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30541586 (View on PubMed)

Other Identifiers

22436

Identifier Type: -

Identifier Source: org_study_id