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

Starting soon · Not applicable

Conditions studied: Amplified Musculoskeletal Pain Syndrome (AMPS)

In brief

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).

Key facts

Study ID

NCT07249931

Run by

Children's Health

People needed

40

Starts

2025-12-01

Expected to finish

2028-12-31

Last updated by the study team

2025-11-25

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Medical Center - Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.