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

Children's Health

Status

Not yet enrolling

Conditions

Amplified Musculoskeletal Pain Syndrome (AMPS)

Treatments

Device: Nerivio(R) Device

Other: Usual Care

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07249931

Nerivio Protocol

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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