Stanford Center for Back Pain

NCT02503475 | Active Not Recruiting DMC

• 1 other identifier: 22436
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Changes in pain severity

  Visual Analogue Scale from 0 to 100, where 0=no pain and 100=worst pain imaginable

  Up to 12 months post-treatment

Secondary Outcomes (1)

• Changes in pain symptom severity and well being

  Up to 12 months post-treatment

Study Arms (3)

Project 1- Real-Time fMRI

OTHER

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

Project 2 - CBT/MBSR

EXPERIMENTAL

This arm investigates 2 experimental groups: Cognitive Behavioral Therapy (CBT) Mindfulness Based Stress Reduction (MBSR)

Behavioral: CBT or MBSR

Project 3- Acupuncture

OTHER

This arm investigates Acupuncture within 2 groups: Verum- Experimental Sham- Sham comparator

Device: Acupuncture

Interventions

Real-Time fMRI 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 1- Real-Time fMRI

CBT or MBSR 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 2 - CBT/MBSR

Acupuncture DEVICE

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

Project 3- Acupuncture

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• 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.

  PMID: 36759316 DERIVED

• 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.

  PMID: 36166279 DERIVED

• 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.

  PMID: 30541586 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sean Mackey, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• James Gross, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Rachel Manber, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sean Mackey, MD, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 21, 2015
• Study Start: March 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)