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Not yet recruiting NCT07249931

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

No phase Interventional Amplified Musculoskeletal Pain Syndrome (AMPS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerivio(R) Device, Usual Care.
Who it may be relevant to
Registry conditions: Amplified Musculoskeletal Pain Syndrome (AMPS). Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
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Official title

Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients: A Nurse Practitioner-Led Pilot Study

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).

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.

Primary outcome measures

  • Treatment [Time frame: over a four-week intervention period.]
Secondary outcome measures (1)
  • Frequency of as needed pain medications [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Medical Center - Dallas — Dallas

Identifiers

NCT: NCT07249931 · Nerivio Protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗