Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06310226

Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

Led by University of California, Los Angeles · Updated on 2026-02-13

20

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact.

CONDITIONS

Official Title

Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give informed consent and follow study procedures and visits
  • Male or female aged 18 to 80 years inclusive
  • Current chronic low back pain lasting more than 3 months and present on more than 50% of days in the past 6 months
  • Already receiving spinal cord stimulator treatment for chronic low back pain
  • Able to use lower extremities
  • Able to tolerate fMRI and neurophysiological tests
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent due to decision-making incapacity
  • Medical conditions interfering with study procedures, pain reporting, or endpoint evaluation
  • Lifetime history of certain psychiatric disorders (schizophrenia, bipolar with psychosis, other psychotic disorders) or current suicidal thoughts
  • Presence of any implant or stimulation device other than a spinal cord stimulator
  • Life expectancy under 1 year
  • Pregnant or nursing without reliable birth control, surgical sterilization, or 2 years post-menopause
  • History of substance abuse or dependency (excluding marijuana use)
  • Current or recent participation in another clinical trial (within 30 days)
  • Current treatment with electroconvulsive therapy or transcranial magnetic stimulation
  • Conditions preventing brain fMRI assessment, including prior brain injury, surgery, dementia, neurological or psychiatric illness, sensory impairments, low birth weight or early gestational age
  • MRI contraindications such as claustrophobia, pacemaker, vascular stents, or metal implants
  • History of spine surgery with failed instrumentation or pseudarthrosis causing pain
  • Any other condition making participation unsuitable or noncompliant in the investigator's opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

L

Lily Chau, MD, PhD

CONTACT

D

Daniel C Lu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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