← Back to Search

Procedure

Multimodal Therapies for Chronic Back Pain

N/A

Waitlist Available

Led By Sean Mackey, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing four different treatments for chronic low back pain to see which is most effective.

Who is the study for?

This trial is for English-speaking adults with chronic low back pain as defined by the NIH task force. It's not suitable for those who can't have an MRI, are pregnant or planning to become pregnant, have certain medical conditions, neurological disorders like seizures or stroke, or mental health conditions that could affect participation.

What is being tested?

The Stanford Center for Back Pain is testing four treatments: real-time fMRI neurofeedback (brain activity feedback), mindfulness-based stress reduction (MBSR), cognitive behavioral therapy (CBT), and acupuncture to understand how they work and their effectiveness in treating chronic lower back pain.

What are the potential side effects?

While the study doesn't specify side effects, generally speaking, fMRI has no known side effects; CBT/MBSR may cause temporary emotional discomfort; acupuncture might cause minor bruising or bleeding at needle sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic low back pain or I am healthy without back pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in pain severity

Secondary study objectives

Changes in pain symptom severity and well being

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Project 3- AcupunctureExperimental Treatment1 Intervention

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

Group II: Project 2 - CBT/MBSRExperimental Treatment1 Intervention

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

Group III: Project 1- Real-Time fMRIExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240

0 / 1Eligibility criteria met