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.
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,
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).
Parallel
SCS-PNE intervention
BehavioralThe 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.
Tampa Scale for Kinesiophobia (TSK-11)
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)
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)
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)
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.
PNE helpfulness
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
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
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:
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.
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