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

N/ANot Yet RecruitingNCT07249931

Children's Health40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amplified Musculoskeletal Pain Syndrome (AMPS)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment

Measure change from baseline in pain scores to reported pain scores after using the Nerivio device for pediatric patients with AMPS.

Time frame: over a four-week intervention period.

Secondary Outcomes

Frequency of as needed pain medications

Evaluate frequency in PRN medications for pain in both the participants using the Nerivio device and those with only the traditional treatment plan.

Time frame: 4 weeks