Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in P… (NCT07249931) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients
United States40 participantsStarted 2025-12-01
Plain-language 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).
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.