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

November 18, 2025 updated by: Elizabeth Wong, Children's Health

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Patients with AMPS in the control group will use their usual practices to control pain.
Other: Usual Care
Patients will use their usual care to treat pain.
Experimental: Intervention group
Patients in the experimental group will use the Nerivio(R) device once every 48 hours.
Device: Nerivio(R) Device
Patients will use the Nerivio(R) device once every 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment
Time Frame: over a four-week intervention period.
Measure change from baseline in pain scores to reported pain scores after using the Nerivio device for pediatric patients with AMPS.
over a four-week intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of as needed pain medications
Time Frame: 4 weeks
Evaluate frequency in PRN medications for pain in both the participants using the Nerivio device and those with only the traditional treatment plan.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality
Time Frame: 4 weeks
o Examine changes in functional outcomes, including school attendance, physical activity, and quality of life following the use of the device as reported by subjects.
4 weeks
Satisfaction and Adherence of Nerivio Device use
Time Frame: every week for a total of 4 weeks
Determine patient and caregiver satisfaction and adherence to the Nerivio treatment protocol through a series of question via weekly questionnaire.
every week for a total of 4 weeks
Safety and tolerability
Time Frame: 4 weeks
Evaluate the safety and tolerability of the Nerivio device in the pediatric AMPS population by reviewing any incident reports or complaints from the subjects.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Health

Collaborators

Theranica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 6, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nerivio Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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