Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Johns Hopkins University
Summary
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.
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 continu…
Eligibility
- Age range
- 5–26 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceScrambler 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.
Location
- Johns Hopkins Children's CenterBaltimore, Maryland