Virtual Pain Neuroscience Education for Patients Undergoing Spinal Cord Stimulation: A Hybrid Effectiveness-Implementation Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 50
- Primary Endpoint
- Tampa Scale for Kinesiophobia (TSK-11)
Study Overview
Brief 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.
Detailed Description
(Methodology and Scientific Framework Narrative) This study is structured as a hybrid effectiveness-implementation pilot study designed to systematically evaluate a virtual delivery model for integrating a behavioral pain intervention into neuromodulation care. The protocol operationalizes core Translational Science Principles within a cross-disciplinary team science framework to optimize clinical workflows and enhance patient-centered outcomes for individuals suffering from treatment-resistant pain.
The scientific methodology focuses on evaluating the clinical feasibility and implementation metrics of a synchronized, multi-part telehealth curriculum. By utilizing a secure virtual platform, the study examines remote tracking consistency and patient accessibility, determining how a virtual behavioral protocol can be integrated into active interventional pain clinic workflows without disrupting standard medical device management.
Methodologically, the intervention targets specific cognitive-behavioral mediators (factors) that traditionally limit the long-term efficacy of spinal cord stimulators. The analysis will measure the feasibility of the virtual PNE delivery model to successfully impact key patient-reported outcomes. Specifically, the study tracks changes in maladaptive cognitive patterns-primarily pain catastrophizing and pain-related anxiety-and evaluates the concurrent promotion of psychological resilience factors. The ultimate objective of this trial is to determine if adding the virtual PNE intervention successfully helps patients improve across these clinical and behavioral scales compared to receiving standard spinal cord stimulation care alone.
Simultaneously, this protocol tests an objective pain assessment methodology as an exploratory study variable. Utilizing brief, non-invasive vocal recordings captured at two points during the pilot study during remote telehealth assessments, the study performs acoustic feature extractions on sustained phonations of the /ah/ vowel sound. These objective acoustic metrics are quantitatively modeled across two distinct clinical states: periods of controlled pain and periods of uncontrolled pain. This exploratory analysis evaluates the correlation between objective vocal biomarkers and the standardized clinical scales measuring pain catastrophizing, anxiety, depression, and resilience. The ultimate objective of this exploratory variable is to determine if specific acoustic features can serve as a reliable, non-invasive digital biomarker for tracking longitudinal pain severity and treatment response in remote settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(pilot study Aim 3):
- •presence of a scheduled spinal cord stimulator trial surgery date within the EPIC workbench report,
- •age greater than or equal to 18 years,
- •ability to speak, read, and understand English to complete study surveys and participate in educational sessions,
- •consistent access to an internet-enabled device (smartphone, tablet, or computer) equipped with a working camera and microphone compatible with the virtual intervention delivery,
- •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):
- •diagnosis of a severe cognitive impairment, advanced dementia, or active psychosis,
- •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).
Arms & Interventions
normal spinal cord stimulation care
This arm will include normal SCS care without the PNE intervention
SCS-PNE intervention
this 2nd arm will include the SCS-PNE as an intervention
Intervention: SCS-PNE intervention (Behavioral)
Outcomes
Primary Outcomes
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
Fear of movement and physical activity will be assessed using the 11-item short form of the Tampa Scale for Kinesiophobia (TSK-11). The TSK-11 is an abbreviated version of the original 17-item scale developed by Kori and colleagues, designed to measure a patient's irrational, debilitating, and fear-driven belief that physical movement will cause reinjury or aggravate their chronic pain condition.
Hospital Anxiety and Depression Survey (HADS)
Time Frame: HADS 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 visit
Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a widely validated 14-item self-report instrument originally developed by Zigmond and Snaith. The HADS is specifically designed for use in non-psychiatric medical clinic populations to identify emotional distress while deliberately excluding somatic symptoms (such as fatigue, dizziness, or headaches) that could otherwise confound scores in patients with chronic physical conditions or those undergoing medical interventions.
Pain Catastrophizing Scale (PCS)
Time Frame: PCS 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 visit
Pain-related catastrophic thinking will be assessed using the PCS, a 13-item self-report measure that evaluates maladaptive cognitive and emotional responses to pain. The PCS assesses three domains: rumination, magnification, and helplessness. Participants rate the extent to which they experience specific thoughts and feelings when in pain using a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("All the time"). Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. The PCS is widely used in chronic pain research and has demonstrated strong reliability and construct validity across clinical populations.
Connor-Davidson Resilience Scale- 10 Item Version (CD-RISC-10)
Time Frame: CD 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 visit
Psychological resilience will be assessed using the 10-item CD-RISC-10, a brief self-report measure designed to assess the ability to cope with adversity and adapt to stress. Participants rate items on a 5-point Likert scale ranging from 0 ("Not true at all") to 4 ("True nearly all the time"). Total scores range from 0 to 40, with higher scores indicating greater resilience. The CD-RISC-10 has demonstrated good internal consistency and construct validity across medical and mental health populations.
Pain Intensity, Enjoyment of Life, Interference with General Activity (PEG) Scale
Time Frame: PEG 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 visit
Pain intensity and its functional impact on daily life will be assessed using the PEG scale, a ultra-brief, 3-item self-report instrument derived from the Pain Interference subscale of the Brief Pain Inventory (BPI). The PEG scale is specifically designed to minimize respondent burden in busy clinical workflows while capturing the multi-dimensional nature of chronic pain across three critical domains: average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: 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 visit
Fear of movement and physical activity will be assessed using the 11-item short form of the Tampa Scale for Kinesiophobia (TSK-11). The TSK-11 is an abbreviated version of the original 17-item scale developed by Kori and colleagues, designed to measure a patient's irrational, debilitating, and fear-driven belief that physical movement will cause reinjury or aggravate their chronic pain condition.
Secondary Outcomes
- PNE helpfulness(PNE helpfulness collected at 4 time points: 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 visit)
- SCS Expectation Rating(SCS expectation rating at 3 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)
- SCS Outcome Rating(SCS outcoming rating at 2 time points: T3= 4-6 weeks after 2nd PNE visit T4= 8-10 weeks after 2nd PNE visit)
- Submission of /ah/ voice sample:(/ah/ sample collected at 2 time points: T3= 4-6 weeks after 2nd PNE visit T4= 8-10 weeks after 2nd PNE visit)
- FIM(FIM collected at 2 time points: 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)
- AIM(AIM helpful collected at 2 time points: 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)
- Submission of voice samples:(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 visit)