Chronic pain is a leading cause of disability in the United States. When standard treatments fail, many patients develop treatment resistant pain and undergo Spinal Cord Stimulation (SCS) therapy. SCS uses an implanted device to send mild electrical currents to the spine to block pain signals before they reach the brain. However, long-term success is often limited by how a patient's nervous system and brain process chronic pain, as well as psychological factors like anxiety and excessive worrying about pain, also known as catastrophizing.
To improve outcomes, this study combines SCS therapy with Pain Neuroscience Education (PNE). PNE is an educational approach that teaches patients how the brain and nervous system handle pain signals, reframing pain as a process that can be changed rather than just ongoing tissue damage. The goal of this pilot trial is to test the feasibility of using virtual, remote PNE sessions to help patients reduce pain catastrophizing and anxiety, while building overall psychological resilience. Additionally, the study explores an innovative, objective way to monitor pain levels by analyzing short voice recordings. Researchers want to see if specific vocal features change when a person's pain is well-controlled versus when it is uncontrolled.
Participants enrolled in this study will receive either 1) standard spinal cord stimulation or 2) spinal cord stimulation plus the intervention--a virtual, multi-session PNE delivered remotely over a secure telehealth platform. Throughout the study, participants will complete standard clinical surveys to measure their physical function, anxiety, pain catastrophizing, and emotional resilience using standardized tools. Participants will also provide short voice recordings, such as holding a sustained "/ah/" vowel sound, during their virtual assessments. This allows researchers to safely evaluate the direct relationship between subtle voice patterns and reported clinical pain levels.
Inclusion Criteria (pilot study Aim 3):
Exclusion Criteria (pilot study):
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While this behavioral trial is open-label for participants and the coordinators delivering the sessions, a blinding protocol is maintained for data evaluation to protect the integrity of the analysis. The "Outcomes Assessors" include the biostatisticians conducting the statistical modeling and the K12 project mentors overseeing data review.
To achieve this while allowing for appropriate data analysis, all patient-reported behavioral scales and exploratory acoustic voice metrics will be de-identified and assigned to masked group codes (e.g., "Group A" and "Group B") by a separate study team member prior to evaluation. This approach provides the analysis team with the necessary group structures to pursue and execute the correct statistical analyses, while keeping them blinded to which specific code represents the active intervention arm versus the standard care control arm. Group identities will not be revealed until the primary statistical models are complete.
This arm will include normal SCS care without the PNE intervention
this 2nd arm will include the SCS-PNE as an intervention
HCharton@uams.edu501-686-4788
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