Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT07264920
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.
Study:
NCT07264920
Study Brief:
Protocol Section:
NCT07264920