Electrocutaneous Analgesia for Neuropathic Pain
(PEACE-NP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat nerve pain in children with cancer that has spread to their bones. The focus is on the Scrambler Therapy MC-5A Device, which sends gentle electrical signals through the skin to transform painful sensations into non-painful ones. The aim is to reduce pain and decrease the need for pain medication, improving daily life for the children. Children with cancer who experience intermittent or persistent pain may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity for children to potentially experience pain relief through innovative technology.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it aims to reduce reliance on pain medications. It's best to discuss this with the trial coordinators.
What prior data suggests that the Scrambler Therapy device is safe for pediatric oncology patients with neuropathic pain?
Research shows that Scrambler Therapy is generally easy for people to handle. The device sends gentle electrical signals through pads placed on the skin near the pain area, transforming pain signals into non-painful ones. Studies have found that this treatment is safe for individuals with long-term pain, even for those who haven't found success with other pain treatments. Serious side effects are rare, and any that occur are usually mild, such as temporary skin irritation where the pads are placed. This makes the treatment safe for use in various settings, including hospitals and clinics.12345
Why are researchers excited about this trial?
Unlike traditional treatments for neuropathic pain, which often involve medications like opioids or anticonvulsants, Scrambler Therapy stands out due to its non-invasive approach. It uses the MC-5A device to deliver low-level electrical signals through surface electrodes placed near the pain site. These signals "scramble" pain messages, converting them into non-painful sensations, which is a novel mechanism of action compared to standard pharmacological methods. Researchers are excited about this therapy because it offers a drug-free alternative that could potentially reduce side effects and dependency risks associated with long-term medication use.
What evidence suggests that the Scrambler Therapy device is effective for neuropathic pain?
Research has shown that the Scrambler Therapy MC-5A device, used by participants in this trial, can effectively reduce nerve pain. In one study, patients reported a 42% drop in pain levels from the beginning to the end of treatment. Another study found that it eased long-term nerve pain more effectively than standard medications. More than half of the patients experienced a reduction from severe to mild pain after using the device. This non-invasive therapy uses electrical signals to transform pain messages into non-painful ones, potentially reducing reliance on pain medication.36789
Who Is on the Research Team?
Joann Hunsberger, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for children with cancer-related neuropathic pain due to metastatic bone disease. They should be experiencing chronic or nerve pain and looking for non-invasive treatment options.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 5 to 10 Scrambler Therapy sessions over 1-2 weeks, with pain assessed before and after each session
Follow-up
Participants are monitored for durability of pain relief and changes in medication use at 1, 3, and 6 months post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Scrambler Therapy MC-5A Device
Trial Overview
The study tests the Scrambler Therapy MC-5A Device, a non-invasive tool designed to alleviate neuropathic pain in pediatric oncology patients without relying heavily on systemic pain medications.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Citations
Scrambler therapy: what's new after 15 years? The results ...
At T0 15.9% of patients reported mild pain, 31.1% moderate, and 53.0% severe. At T2 the pain appeared mild in 67.1% of patients, moderate in ...
Scrambler Therapy May Relieve Chronic Neuropathic Pain ...
In this pilot randomized trial, Scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based drug management.
Scrambler Therapy Treatment: The Importance of Examining ...
In the active ST group, the highest mean for pain intensity scores was at baseline (M = 4.3, SD = 1.4), which decreased by 42% posttreatment (M ...
Differential response to scrambler therapy by neuropathic ...
Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares ...
NCT02722434 | MC5-A Scrambler Therapy or TENS ...
This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients ...
December 23, 2020 Delta International Services & Logistics ...
The ST-5A device has been designed for the pain therapy in hospital, outpatient facility and hospice by trained physicians or other trained ...
Inside the Scrambler Therapy, a Noninvasive Treatment of ...
Scrambler therapy was developed to treat chronic neuropathic pain and cancer pain resistant to opioids and other types of treatments. The goal ...
MEDICAL POLICY - TRANSCUTANEOUS ELECTRICAL ...
Nayback-Beebe et al (2020) reported on the effectiveness of Calmare Scrambler Therapy in military service members with chronic neuropathic pain symptoms.6 Forty ...
K142666.pdf - accessdata.fda.gov
The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses ...
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