Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - Scrambler Therapy MC-5A Device | Experimental | Surface electrodes will be placed near the pain site to deliver low-level electrical signals that "scramble" pain messages into non-painful sensations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prior to first therapy session and immediately following last therapy session |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | immediately prior to and immediately following each session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joann Hunsberger, MD | Contact | 410-955-2448 | jhunsbe1@jhmi.edu | |
| Colleen Mennie, RN, BSN | Contact | 410-955-6412 | cmennie1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joann Hunsberger, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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 | 1 month post therapy sessions, 6 months post therapy sessions |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |