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Responders to spinal cord stimulation for Chronic Lower Back Pain

N/A

Recruiting

Led By Daniel C Lu, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial aims to study how spinal cord stimulators impact functional measures in patients with chronic low back pain. Spinal cord stimulators have shown promise in reducing the need for drugs to manage pain. The

Who is the study for?

This trial is for individuals with chronic low back pain who haven't found relief through long-term medication. It's designed to see if spinal cord stimulators can help reduce pain without the need for drugs, potentially lowering opioid use.Check my eligibility

What is being tested?

The study tests how an epidural electrical spinal cord stimulator affects people with chronic lower back pain. Researchers will look at changes in brain function, nerve activity, walking patterns, and self-reported pain levels.See study design

What are the potential side effects?

Spinal cord stimulation may cause discomfort at the implant site, unwanted tingling or pricking sensations, infection risk from surgery, and potential equipment malfunction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Detection of brain connectivity using functional MRI

Secondary outcome measures

Detection of brain waves using electroencephalography (EEG)

Other outcome measures

Neurological gait kinematics assessment

Neurophysiological functional assessment using pain-related evoked potential (PREP)

Neurophysiological functional assessment using somatosensory evoked potential (SSEP)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Responders to spinal cord stimulationExperimental Treatment1 Intervention

Patients with chronic low back pain, with >50% pain reduction in response to spinal cord stimulation

Group II: Non-responders to spinal cord stimulationExperimental Treatment1 Intervention

Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,248 Total Patients Enrolled

Daniel C Lu, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

3 Previous Clinical Trials

98 Total Patients Enrolled

Lily Chau, MD, PhDStudy DirectorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include individuals aged 85 and above?

"Participants must fall within the age range of 18 to 80 years old to be eligible for this research endeavor. It is noteworthy that there are 8 investigations targeting individuals under 18 and another 252 studies focusing on those over the age of 65."

Answered by AI

Can individuals enroll themselves in this medical research study?

"To participate in this study, individuals must exhibit persistent lower back pain and fall within the age range of 18 to 80. Approximately 20 suitable candidates will be selected for inclusion."

Answered by AI

What is the current number of individuals participating in this research endeavor?

"Yes, the data on clinicaltrials.gov confirms that this study is presently seeking participants. The trial was initially listed on April 1st, 2024, and recently updated on March 12th, 2024. Enrollment aims to include twenty patients from a single site."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Indeed, the details on clinicaltrials.gov highlight that this research study is actively seeking potential participants. The trial was initially uploaded on April 1st, 2024 and last revised on March 12th, 2024. It aims to recruit a total of 20 individuals from one particular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

Daniel Lu, MD, PhD 2024. "Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06310226.

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