Chronic Leg Pain, Chronic Neck Pain, Chronic Pain, Chronic Pain Due to Injury, Failed Back Syndrome, Persistent Spinal Pain Syndrome
Conditions
Keywords
spinal cord stimulation, neuromodulation, pain neuroscience education, pain science education, telehealth, virtual behavioral health, acoustic biomarker, voice analysis, pain catastrophizing, psychological resilence, anxiety and depression, physical therapy
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.
Interventions
BEHAVIORALSCS-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.
Sponsors
University of Arkansas
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale for Kinesiophobia (TSK-11) | 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. |
| Hospital Anxiety and Depression Survey (HADS) | 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) | 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) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | This is designed to see if the virtual neuroscience education actually clicked and felt valuable to them. e.g., Thinking about the educational session on how the nervous system processes pain, how helpful was this information in changing how \[the participant\] thinks about \[the participant's\] pain? (0 = Not at all, 10 = Completely) |
| 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 | This captures participant's baseline mindset and expectations before they receive the actual device. 1. (Relief-focused): Before getting the participant's spinal cord stimulator, how much pain relief does the participant expect it to give the participant? (0 means 'No relief at all' and 10 means 'Complete relief') 2. (Life-focused): How much does the participant expect the spinal cord stimulator to help the participant get back to the participant's daily activities? (0 = Not at all, 10 = A tremendous amount) |
| 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 | This is a post-procedure check-in to see how the hardware is actually performing in the real world. e.g.: 1 (Direct Match to Expectation): Now that the participant has a spinal cord stimulator, how much pain relief has it actually given? (0 means 'No relief at all' and 10 means 'Complete relief') 2 (Overall Satisfaction): Overall, how satisfied is the participant with the results of the spinal cord stimulator so far? (0 = Not satisfied at all, 10 = Completely satisfied) |
| 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 | Building on clinical collaborative team science pilot findings, the investigators will collect brief sustained phonation voice samples (ah, e, oo), as an exploratory objective. Emerging evidence suggests chronic pain may be reflected in quantifiable acoustic features, raising questions about whether such features vary with symptom severity or respond to intervention. Voice samples will be captured under two distinct clinical states, based on the participant's pain experiences following SCS surgery: 1) during an acute pain episode, and 2) during a state of controlled or minimal pain. |
| 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 | Feasibility of Intervention Measure rating 1-5. ie to question: Participating in this pain education seems doable for me. Response scale: 1. = Completely Disagree 2. = Disagree 3. = Neither Agree nor Disagree 4. = Agree 5. = Completely Agree |
| 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 | Acceptability of Intervention Measure, rating 1-5; ie to question: I like the idea of including this pain education in my care. Response scale: 1. = Completely Disagree 2. = Disagree 3. = Neither Agree nor Disagree 4. = Agree 5. = Completely Agree |
Contacts
CONTACTLeah R Tobey-Moore, DPT, MBA, MSCTS
CONTACTHeidi N Charton, BA, CRS
PRINCIPAL_INVESTIGATORLeah R Tobey-Moore, DPT, MBA, MSCTS
UAMS
Outcome results
None listed