Chronic Pain Due to Injury / Failed Back Syndrome / Chronic Pain · Interventional Study

Virtual Pain Education for Spinal Cord Stimulation Patients

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered pilot trial combining spinal cord stimulation with virtual pain neuroscience education in patients with chronic pain, designed to measure changes in kinesiophobia, anxiety, catastrophizing, resilience, and pain intensity over 8–10 weeks post-intervention. No results are yet available; the trial has not begun recruitment.

What was studied

Interventional, Randomized, Parallel, Single masking, Health Services Research purpose. Chronic Pain, Chronic Pain Due to Injury, Failed Back Syndrome, Persistent Spinal Pain Syndrome, Chronic Leg Pain, Chronic Neck Pain; age from 18 Years. Intervention: SCS-PNE intervention. Compared with: normal spinal cord stimulation care — No Intervention. n = 50. Not stated in registry record..

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This pilot will assess feasibility and signal of benefit for combining virtual pain neuroscience education with SCS therapy. Results are needed before recommendations can be made for clinical practice.

Plain-language summary

This is an unstarted pilot trial of a behavioral intervention combined with SCS, designed to test feasibility and measure psychological and voice-based outcomes; no results are reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Tampa Scale for Kinesiophobia (TSK-11) (assessed at TSK-11 collected at 5 time points: T0=baseline visit T1= 2 weeks before SCS tri…); Hospital Anxiety and Depression Survey (HADS) (assessed at HADS collected at 5 time points: T0=baseline visit T1= 2 weeks before SCS trial…); Pain Catastrophizing Scale (PCS) (assessed at PCS collected at 5 time points: T0=baseline visit T1= 2 weeks before SCS trial…); Connor-Davidson Resilience Scale- 10 Item Version (CD-RISC-10) (assessed at CD collected at 5 time points: T0=baseline visit T1= 2 weeks before SCS trial w…); Pain Inte…

DesignInterventional, Randomized, Parallel, Single masking, Health Services Research purpose

PopulationChronic Pain, Chronic Pain Due to Injury, Failed Back Syndrome, Persistent Spinal Pain Syndrome, Chronic Leg Pain, Chronic Neck Pain; age from 18 Years

Sample size50

InterventionSCS-PNE intervention

Comparatornormal spinal cord stimulation care — No Intervention

SettingNot stated in registry record.

Reported figures

Quoted from the source exactly as published.

Planned sample size50

Primary outcome measure 1Tampa Scale for Kinesiophobia (TSK-11)

Primary outcome measure 2Hospital Anxiety and Depression Survey (HADS)

Primary outcome measure 3Pain Catastrophizing Scale (PCS)

Primary outcome measure 4Connor-Davidson Resilience Scale-10 Item Version (CD-RISC-10)

Primary outcome measure 5Pain Intensity, Enjoyment of Life, Interference with General Activity (PEG) Scale

Assessment timepoints5 (baseline, 2 weeks pre-trial, 2 weeks pre-implant, 4–6 weeks post-intervention, 8–10 weeks post-intervention)

Clinical bottom line

Caveats

Study has not yet begun recruitment; no outcome data are available.
Primary outcomes are psychological and exploratory voice biomarkers, not hard clinical endpoints (e.g., pain relief, functional recovery, device explantation).
Sample size (50) is pilot-scale; underpowered for definitive efficacy claims.
Comparator arm structure and blinding procedures not fully described in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional pilot with planned behavioral intervention and comparator arm structure.

Directness

moderate

Combines SCS with pain neuroscience education; primary outcomes are psychological (kinesiophobia, anxiety, catastrophizing) and exploratory (voice biomarkers).

Consistency

insufficient

No results reported; this is a registry record of a planned study not yet recruiting.

Risk of bias

insufficient

Study design and blinding status not fully specified in registry record.

Sample adequacy

limited

Estimated enrollment 50 participants; pilot-scale sample for feasibility assessment.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07743905). This is a study registration, not published results. Lead sponsor: University of Arkansas. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Chronic Pain, Chronic Pain Due to Injury, Failed Back Syndrome, Persistent Spinal Pain Syndrome, Chronic Leg Pain, Chronic Neck Pain. Interventions: BEHAVIORAL: SCS-PNE intervention. Primary outcome measures: Tampa Scale for Kinesiophobia (TSK-11) , 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) , 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) , 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) , 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 , 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of ArkansasNCT07743905Chronic Pain Due to InjuryFailed Back SyndromeChronic PainSCS-PNE intervention