Health TrialsbyHealthPanel

Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

ConditionsNeuropathic PainChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-26
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to verbalize pain scores

Oncology patients with acute and/or chronic pain

Disqualifiers

Patients with Implantable Devices

Epilepsy

Pregnancy

A history of myocardial infarction or ischemic heart disease within the past six months

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Treatment - Scrambler Therapy MC-5A DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale

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.

Time frame
Prior to first therapy session and immediately following last therapy session

Secondary outcomes

1

Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.

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

Time frame
immediately prior to and immediately following each session
2

Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions.

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

Time frame
Prior to first therapy session and immediately after final therapy session
3

Change in number of medications used, daily morphine equivalents for opioids

This will be obtained through medical records.

Time frame
Prior to first therapy session up to 1 week following last therapy session.
4

Change in total dose reduction for neuropathic pain

This will be obtained through medical records.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: