An interventional study of SCS-PNE intervention in Chronic Pain, Chronic Pain Due to Injury and Failed Back Syndrome, sponsored by University of Arkansas. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Arkansas · Not applicable, Interventional, and Health services research
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.
(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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria (pilot study):
This arm will include normal SCS care without the PNE intervention
this 2nd arm will include the SCS-PNE as an intervention
Behavioral: SCS-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.
Also known as: pain neuroscience education, pain science education, pain neuroscience education for patients with spinal cord stimulators
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.
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
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.
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
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.
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
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.
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
Pain Intensity, Enjoyment of Life, Interference with General Activity (PEG) Scale
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).
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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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 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.
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
FIM
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
Time frame: 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
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
Time frame: 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
No study locations are listed for this record.
Plan to share: Undecided — A final decision regarding the sharing of individual participant data (IPD) is undecided at this stage. It will be evaluated upon trial completion, depending on institutional review board (IRB) approval for sharing virtual behavioral intervention data, resource availability for de-identification, and the establishment of appropriate data-sharing agreements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.