Virtual Pain Education for Spinal Cord Stimulation Patients

Sponsor
University of Arkansas
Study ID
NCT07743905
Status
Not Yet Recruiting

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Conditions

  • Chronic Leg Pain
  • Chronic Neck Pain
  • Chronic Pain
  • Chronic Pain Due to Injury
  • Failed Back Syndrome
  • Persistent Spinal Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SCS-PNE intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Jul 27, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: normal spinal cord stimulation care
    This arm will include normal SCS care without the PNE intervention
  • Experimental: SCS-PNE intervention
    this 2nd arm will include the SCS-PNE as an intervention

Primary Outcome Measure

Tampa Scale for Kinesiophobia (TSK-11) [ Time Frame: TSK-11 collected at 5 time points: T0=baseline visit T1= 2 weeks before SCS trial within 1 week after 1st PNE visit T2= 2 weeks before permanent implant within 1 week after 2nd PNE visit T3= 4-6 weeks after 2nd PNE visit T4= 8-10 weeks after 2nd PNE vis ]

Central Contacts

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