Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients: A Nurse Practitioner-Led Pilot Study
Children's Health
Summary
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).
Eligibility
- Age range
- 8–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Active autoimmune disease. * Use of implantable electronic medical devices. * Neurological disorders that impair stu…
Interventions
- DeviceNerivio(R) Device
Patients will use the Nerivio(R) device once every 48 hours.
- OtherUsual Care
Patients will use their usual care to treat pain.
Location
- Children's Medical Center - DallasDallas, Texas