Virtual Pain Education for Spinal Cord Stimulation Patients
Not yet recruitingNot applicableNCT07743905
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Virtual Pain Neuroscience Education for Patients Undergoing Spinal Cord Stimulation: A Hybrid Effectiveness-Implementation Pilot Trial
- Conditions
- Chronic Pain
- Chronic Pain Due to Injury
- Failed Back Syndrome
- Persistent Spinal Pain Syndrome
- Chronic Leg Pain
- Chronic Neck Pain
- Interventions
- Behavioral: SCS-PNE intervention
- Sponsor
- University of Arkansas
- Start date
- 2026-09-09
- Primary completion
- 2028-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria (pilot study Aim 3): 1. presence of a scheduled spinal cord stimulator trial surgery date within the EPIC workbench report, 2. age greater than or equal to 18 years, 3. ability to speak, read, and understand English to complete study surveys and participate in educational sessions, 4. consistent access to an internet-enabled device (smartphone, tablet, or computer) equipped with a working camera and microphone compatible with the virtual intervention delivery, 5. willingness and ability to participate in virtual video visits per the SCS-PNE intervention (i.e. through Doximity, Zoom, or EPIC MyChart). Exclusion Criteria (pilot study): 1. diagnosis of a severe cognitive impairment, advanced dementia, or active psychosis, 2. prior formal exposure to structured PNE program within the past 12 months, 3) current involvement in active, unresolved litigation related to their chronic pain condition (i.e., ongoing legal or worker's compensation claim).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07743905