Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain (PEACE-NP)

Johns Hopkins University

Status: Not yet enrolling

Conditions: Neuropathic Pain; Chronic Pain

Treatments: Device: Scrambler Therapy MC-5A Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07264920

IRB00520236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 5 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Treatment - Scrambler Therapy MC-5A Device

Experimental group

Description:

Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.

Treatment:

Device: Scrambler Therapy MC-5A Device