Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients

Официальное название

Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients: A Nurse Practitioner-Led Pilot Study

Обзор

The goal of this trial is to learn how the Nerivio® device works to treat Amplified Musculoskeletal Pain Syndrome (AMPS) in children ages 8-18. Nerivio® is a wearable device that activates specific nerves in the upper arm. This causes a response from the brain that has been helpful for people who experience migrane headaches. The main questions this study aims to answer are: * How well does the Nerivio® device help in reducing pain in children with AMPS? * Does the use of the Nerivio® device help improve quality of life in children with AMPS? * How satisfied are children and their families with the use of the Nerivio® device for treatment of AMPS? Researchers will compare the use of the Nerivio® device with usual treatment for AMPS (including pain medications, physical therapy, and other interventions) to see how well the Nerivio® device helps control pain. Participants will be in one of two groups, decided by: * Those who are in the "control" group will use their usual practices to control pain. * Those who are in the "intervention" group will use the Nerivio® device once every other day. All participants in the "control group" will: * Complete surveys and answer questions about their pain and how it affects their daily life * Use their existing methods for pain control. All participants in the "intervention" group will: * Complete surveys and answer questions about their pain and how it affects their daily life * Learn how to work the Nerivio® device and smartphone app. * Use the Nerivio® device every other day (every 48 hours).

Вмешательства

• Устройство Nerivio(R) Device
  Patients will use the Nerivio(R) device once every 48 hours.
• Другое Usual Care
  Patients will use their usual care to treat pain.

Первичные конечные точки

• Treatment [Срок оценки: over a four-week intervention period.]

Вторичные конечные точки (1)

• Frequency of as needed pain medications [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Confirmed diagnosis of AMPS by a medical provider experienced in pediatric pain management
• Chronic musculoskeletal pain ≥3 months
• Baseline pain intensity of ≥4 on a 0-10/10 Numeric Rating Scale (NRS)
• Able to comprehend and follow instructions for the device use
• Access to compatible smartphone or device to operate the Nerivio app
• Commit to a four-week treatment and data collection period
• Must be age 8 years - 18 years old

Критерии исключения

• Active autoimmune disease.
• Use of implantable electronic medical devices.
• Neurological disorders that impair study participation as determined by the enrolling provider.
• Severe Mood disorders
• Recent change in pain medications or psychotropic medications (within last 4 weeks)
• Currently or plan to be pregnant (Urine or blood HCG testing done upon enrollment)
• Inability to comply with study procedures or use the device as directed

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Medical Center - Dallas — Dallas

Идентификаторы

NCT: NCT07249931 · Nerivio Protocol

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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