Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

NCT ID: NCT07264920

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2030-01-31

Brief 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.

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.

Conditions

Neuropathic Pain; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment - Scrambler Therapy MC-5A Device

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

Group Type: EXPERIMENTAL

Scrambler Therapy MC-5A Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joann Hunsberger, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Joann Hunsberger, MD

Role: CONTACT

jhunsbe1@jhmi.edu

410-955-2448

Colleen Mennie, RN, BSN

Role: CONTACT

cmennie1@jh.edu

410-955-6412

Facility Contacts

Joann Hunsberger, MD

Role: primary

jhunsbe1@jhmi.edu

410-955-2448

Colleen Mennie, RN, BSN

Role: backup

cmennie1@jh.edu

410-955-6412

Other Identifiers

IRB00520236

Identifier Type: -

Identifier Source: org_study_id