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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Johns Hopkins Children's Center
Baltimore, Maryland, United States
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
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
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
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.
Change in total dose reduction for neuropathic pain
This will be obtained through medical records.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Prior to first therapy session up to 1 week following last therapy session.
Durability of pain relief as assessed by the Numerical Rating Scale or the Wong-Baker Faces Pain Scale.
Total score range from 0-10, with a higher score indicating more pain
Time frame: 1 month post therapy sessions, 6 months post therapy sessions