Chronic Pain, Neuropathic Pain
Conditions
Keywords
pediatric oncology, chronic pain, neuropathic pain
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.
Interventions
DEVICEScrambler 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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 26 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale. | 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 |
| Change in pain characteristics measured via the PainDETECT questionnaire, comparing responses from first and final sessions. | 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. |
| Change in number of medications used, daily morphine equivalents for opioids | Prior to first therapy session up to 1 week following last therapy session. | This will be obtained through medical records. |
| Change in total dose reduction for neuropathic pain | Prior to first therapy session up to 1 week following last therapy session. | This will be obtained through medical records. |
| Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale. | 1 month post therapy sessions, 6 months post therapy sessions | Total score range from 0-10, with a higher score indicating more pain |
Countries
United States
Contacts
CONTACTJoann Hunsberger, MD
CONTACTColleen Mennie, RN, BSN
PRINCIPAL_INVESTIGATORJoann Hunsberger, MD
Johns Hopkins University
Outcome results
None listed