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NCT Number: NCT07264920

Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

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.

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Key information

Conditions

Neuropathic Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

5 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scrambler Therapy MC-5A Device

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 outcomes

  1. 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

    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

  1. 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

    Intra-session to session change in pain intensity across the full course of a single Scrambler Therapy session. Total score range from 0-10, with a higher score indicating more pain

  2. 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

    Total score range from 0-38. A higher score indicates a greater likelihood of neuropathic pain.

  3. 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.

    This will be obtained through medical records.

  4. Change in total dose reduction for neuropathic pain

    Time frame: Prior to first therapy session up to 1 week following last therapy session.

    This will be obtained through medical records.

  5. 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

    Total score range from 0-10, with a higher score indicating more pain

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen Mennie, RN, BSN

CONTACT

[email protected]

410-955-6412

Joann Hunsberger, MD

CONTACT

[email protected]

410-955-2448

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: PEACE-NP

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 4, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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