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Chronic PainSCS-PNENCT07743905

Virtual Pain Education for Spinal Cord Stimulation Patients

A study testing SCS-PNE intervention in people with Chronic Pain and Chronic Pain Due to Injury, run by University of Arkansas.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SCS-PNE intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
5 Jan 2027to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

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

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.

Read the 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.

Being tested
SCS-PNE intervention
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
Medical subject headings
Chronic Pain, post laminectomy syndrome, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCS-PNE interventionBehavioural

    Also called pain neuroscience education, pain science education, pain neuroscience education for patients with spinal cord stimulators

    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.

Study groups in NCT07743905
Study groupRoleWhat they receive
normal spinal cord stimulation careNo interventionThis arm will include normal SCS care without the PNE intervention
SCS-PNE interventionExperimentalthis 2nd arm will include the SCS-PNE as an intervention
Receives: Behavioral: SCS-PNE intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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).

    Measured: 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)

  1. 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)

    Measured: 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

  2. 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)

    Measured: 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

  3. 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)

    Measured: SCS outcoming rating at 2 time points: T3= 4-6 weeks after 2nd PNE visit T4= 8-10 weeks after 2nd PNE visit

  4. 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.

    Measured: 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

  5. 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

    Measured: 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

  6. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start5 Jan 2027 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743905
Sponsor's protocol ID
300470
Acronym
SCS-PNE
Status last verified
Oct 2026
First submitted
10 Jul 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Renfro CP, Rome Z, Gatwood J, Hohmeier KC. Use of Rapid Assessment Procedures when analyzing qualitative data in pharmacy research. Res Social Adm Pharm. 2022 Jan;18(1):2249-2253. doi: 10.1016/j.sapharm.2021.05.013. Epub 2021 Jun 6.

    PubMed 34116965

  • Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.

    PubMed 30831273

  • Salazar-Mendez J, Cuyul-Vasquez I, Ponce-Fuentes F, Guzman-Munoz E, Nunez-Cortes R, Huysmans E, Lluch-Girbes E, Viscay-Sanhueza N, Fuentes J. Pain neuroscience education for patients with chronic pain: A scoping review from teaching-learning strategies, educational level, and cultural perspective. Patient Educ Couns. 2024 Jun;123:108201. doi: 10.1016/j.pec.2024.108201. Epub 2024 Feb 10.

    PubMed 38387389

  • Moseley L. Reconceptualising pain according to modern pain science. ResearchGate. doi:10.1179/108331907X223010

  • 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 2007 Sep 12.

    PubMed 17845835

  • Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.

    PubMed 36309746

  • 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.

    PubMed 40417376

  • Alcon C, Zoch C, Luetkenhaus R, Lyman E, Brizzolara K, Goh HT, Wang-Price S. Combined transcranial direct current stimulation and pain neuroscience education for chronic low back pain: a randomized controlled trial. Pain Med. 2025 Feb 1;26(2):90-97. doi: 10.1093/pm/pnae101.

    PubMed 39400579

  • Kasimis K, Apostolou T, Kallistratos I, Lytras D, Iakovidis P. Effects of Manual Therapy Plus Pain Neuroscience Education with Integrated Motivational Interviewing in Individuals with Chronic Non-Specific Low Back Pain: A Randomized Clinical Trial Study. Medicina (Kaunas). 2024 Mar 29;60(4):556. doi: 10.3390/medicina60040556.

    PubMed 38674202

  • Louw A. PAIN NEUROSCIENCE EDUCATION 101 [Internet]. Available from: efaidnbmnnnibpcajpcglclefindmkaj/https://whyyouhurt.com/downloads/PNE-101.pdf

  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PubMed 27351541

  • Hagedorn JM, Falowski SM, Blomme B, Capobianco RA, Yue JJ. Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study. Spine J. 2022 Mar;22(3):379-388. doi: 10.1016/j.spinee.2021.08.005. Epub 2021 Aug 20.

    PubMed 34419628

  • Wolter T, Fauler I, Kieselbach K. The impact of psychological factors on outcomes for spinal cord stimulation: an analysis with long-term follow-up. Pain Physician. 2013 May-Jun;16(3):265-75.

    PubMed 23703413

  • Bendinger T, Plunkett N, Poole D, Turnbull D. Psychological Factors as Outcome Predictors for Spinal Cord Stimulation. Neuromodulation. 2015 Aug;18(6):465-71; discussion 471. doi: 10.1111/ner.12321. Epub 2015 Jun 11.

    PubMed 26095096

  • Beletsky A, Music S, Liu C, Vickery K, Hurlock N, Winston N, Loomba M, Suvar T, Chen J, Gabriel RA. Long-Term Outcomes After Spinal Cord Stimulator Placement in Patients with Pre-procedural Active Opioid Use Versus Patients Who Were Opioid-Naive. Pain Physician. 2024 Jan;27(1):69-77.

    PubMed 38285037

Questions about this trial

What is this clinical trial studying?

A study testing SCS-PNE intervention in people with Chronic Pain and Chronic Pain Due to Injury, run by University of Arkansas.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leah R Tobey-Moore, DPT, MBA, MSCTS (501.526.8332, ltobeymoore@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tampa Scale for Kinesiophobia (TSK-11) (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07743905, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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