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Virtual Pain Education for Spinal Cord Stimulation Patients
Sponsor: University of Arkansas
Summary
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.
Official title: Virtual Pain Neuroscience Education for Patients Undergoing Spinal Cord Stimulation: A Hybrid Effectiveness-Implementation Pilot Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-27
Completion Date
2028-06-30
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
SCS-PNE intervention
The SCS-PNE intervention integrates standard neuromodulation with a multi-session Pain Neuroscience Education (PNE) curriculum delivered via a secure virtual telehealth platform. This delivery model optimizes clinical workflows and patient accessibility by eliminating in-person clinic visits and travel. The curriculum targets central nervous system sensitization by teaching patients how the brain processes chronic pain, reframing it as a modifiable process rather than ongoing tissue damage. Distinguishing this protocol from traditional trials, the virtual curriculum's design is directly informed by Aim 1 qualitative stakeholder interviews with past spinal cord stimulation (SCS) patients, clinicians, and SCS company patient representatives. The intervention is explicitly structured to evaluate the feasibility of reducing specific patient-reported cognitive-behavioral barriers (e.g. pain catastrophizing and anxiety), while tracking the promotion of resilience factors.