Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Able to give informed consent for participation in the trial and be able to comply with study-related requirements, procedures, and visits

• Male or female, between the ages of 18 and 80 years (inclusive)

• Current self-report of chronic low back pain (pain between the lower posterior margin of the rib cage and the horizontal gluteal fold), which has persisted for \> the past 3 months AND has resulted in pain on \> 50% of days in the past 6 months\* (\*Chronic low back pain criteria as defined by the NIH Pain Consortium Research Task Force (RTF) and BACPAC Minimum Dataset Working Group)

• Already undergoing spinal cord stimulator treatment for chronic low back pain

• Able to use their lower extremities

• Able to tolerate fMRI and neurophysiological evaluation

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Lily Chau, MD, PhD
lilychau@mednet.ucla.edu
310-267-1770
Backup
Daniel C Lu, MD, PhD
dclu@mednet.ucla.edu
310-319-3475
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 20
Treatments
Experimental: Responders to spinal cord stimulation
Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation
Experimental: Non-responders to spinal cord stimulation
Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov