MedTrace Logo

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

NCT07249931 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-25

No results posted yet for this study

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).

Conditions

  • Amplified Musculoskeletal Pain Syndrome (AMPS)

Interventions

DEVICE

Nerivio(R) Device

Patients will use the Nerivio(R) device once every 48 hours.

OTHER

Usual Care

Patients will use their usual care to treat pain.

Sponsors & Collaborators

  • Theranica

    collaborator INDUSTRY

  • Children's Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249931 on ClinicalTrials.gov