Virtual Pain Education for Spinal Cord Stimulation Patients

NCT07743905 | Not Yet Recruiting DMC

• 1 other identifier: 300470
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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

• 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.

  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.

  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.

  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).

  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

Secondary Outcomes (6)

• 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

Study Arms (2)

normal spinal cord stimulation care

NO INTERVENTION

This arm will include normal SCS care without the PNE intervention

SCS-PNE intervention

EXPERIMENTAL

this 2nd arm will include the SCS-PNE as an intervention

Behavioral: SCS-PNE intervention

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.

Also known as: pain neuroscience education, pain science education, pain neuroscience education for patients with spinal cord stimulators

SCS-PNE intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arkansas: lead

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MeSH Terms

Conditions

Chronic Pain; post laminectomy syndrome; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Leah R Tobey-Moore, DPT, MBA, MSCTS

  UAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah R Tobey-Moore, DPT, MBA, MSCTS

CONTACT

501.526.8332; ltobeymoore@uams.edu

Heidi N Charton, BA, CRS

CONTACT

501-686-4788; HCharton@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 4, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07