Clinical trial · Interventional
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
NCT07264920CI-TRIAL-00121333PEACE-NPnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study evaluating the Scrambler Therapy device as a non-invasive treatment for neuropathic pain in pediatric oncology patients with metastatic bone disease. The primary goal is to assess changes in pain intensity and medication use, aiming to improve quality of life and reduce reliance on systemic pain medications.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scrambler Therapy MC-5A Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment - Scrambler Therapy MC-5A Device
- description
- Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.
- interventionNames
- Device: Scrambler Therapy MC-5A Device
Primary outcomes (1)
- measure
- Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale
- timeFrame
- Prior to first therapy session and immediately following last therapy session
- description
- The primary outcome is the change in self-reported pain intensity from baseline (prior to the first Scrambler Therapy session) to the post-final Scrambler Therapy session as measured by Numerical Rating Scale (NRS) or Wong-Baker Faces Pain Scale. The patients will rate pain using one of these scales at the beginning and the end of each treatment session with the primary comparison between the pre-first treatment session and the post-final treatment session. Total score range from 0-10, for both scales with a higher score indicating more pain.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Able to verbalize pain scores * Oncology patients with acute and/or chronic pain Exclusion Criteria: * Patients with Implantable Devices * Epilepsy * Pregnancy * A history of myocardial infarction or ischemic heart disease within the past six months * History of severe heart arrhythmia or equivalent heart disease * Open Wounds or Infections at site of electrode placement * A history of intolerance to transcutaneous electronic nerve stimulation
References
Publications (0)
Data not yet available
No reference posted for this study.