Virtual Pain Education for Spinal Cord Stimulation Patients

Официальное название

Virtual Pain Neuroscience Education for Patients Undergoing Spinal Cord Stimulation: A Hybrid Effectiveness-Implementation Pilot Trial

Обзор

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.

Подробное описание

(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.

Вмешательства

• Поведенческое 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. Dis

Первичные конечные точки

• Tampa Scale for Kinesiophobia (TSK-11) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (6)

• PNE helpfulness [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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: [Срок оценки: /ah/ sample collected at 2 time points: T3= 4-6 weeks after 2nd PNE visit T4= 8-10 weeks after 2nd PNE visit]
• FIM [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007 Nov;132(1-2):179-88. doi: 10.1016/j.pain.2007.07.028. Epub PMID 17845835
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• Moseley GL, Mardon A, Watson J, Braithwaite F, Wilson MV, Barker T, Lawrence J, Sheppard D, Reneman MF, Stinson J, Ryan CG. From didactic explanations to co-design, sequential art and embodied learning: challenges, criticisms and future directions of patient pain education. Front Pain Res (Lausanne). 2025 May 9;6:1536112. doi: 10.3389/fpain.2025.1536112. eCollection 2025. PMID 40417376
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Идентификаторы

NCT: NCT07743905 · 300470

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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