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Not yet recruiting NCT07264920

Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

No phase Interventional Neuropathic Pain Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scrambler Therapy MC-5A Device.
Who it may be relevant to
Registry conditions: Neuropathic Pain, Chronic Pain. Basic parameters: 5 years — 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

Eligible participants (ages 5-26) will undergo 5 to 10 therapy sessions over 1-2 weeks, with pain assessed before and after each session using age-appropriate scales. Additional assessments include the PainDETECT questionnaire and follow-ups at 1, 3, and 6 months to evaluate durability of pain relief and changes in medication use.

The study will enroll up to 70 participants over 5 years, with an expected evaluable sample size of 60. Statistical analyses will compare pre- and post-treatment pain scores, track pain trends across sessions, and assess long-term outcomes. Participants will continue receiving routine care, and therapy will be adjusted based on individual responses.

Interventions

  • Device Scrambler Therapy MC-5A Device
    Scrambler Therapy is a non-invasive electrocutaneous analgesia technique used to treat neuropathic pain. Each session lasts approximately 30-45 minutes and involves placing surface electrodes near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations. Pain intensity will be measured before and after each session.

Primary outcome measures

  • Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale [Time frame: Prior to first therapy session and immediately following last therapy session]
Secondary outcome measures (5)
  • Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale. [Time frame: immediately prior to and immediately following each session]
  • Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions. [Time frame: Prior to first therapy session and immediately after final therapy session]
  • Change in number of medications used, daily morphine equivalents for opioids [Time frame: Prior to first therapy session up to 1 week following last therapy session.]
  • Change in total dose reduction for neuropathic pain [Time frame: Prior to first therapy session up to 1 week following last therapy session.]
  • Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale. [Time frame: 1 month post therapy sessions, 6 months post therapy sessions]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Johns Hopkins Children's Center — Baltimore

Identifiers

NCT: NCT07264920 · IRB00520236

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗