NCT07249931

Brief 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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

November 6, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 6, 2025

Last Update Submit

November 18, 2025

Conditions

Amplified Musculoskeletal Pain Syndrome (AMPS)

Keywords

Amplified Musculoskeletal Pain Syndrome (AMPS)Pediatrics

Outcome Measures

Primary Outcomes (1)

  • Treatment

    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 Outcomes (1)

  • Frequency of as needed pain medications

    4 weeks

Other Outcomes (3)

  • Functionality

    4 weeks

  • Satisfaction and Adherence of Nerivio Device use

    every week for a total of 4 weeks

  • Safety and tolerability

    4 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients with AMPS in the control group will use their usual practices to control pain.

Other: Usual Care

Intervention group

EXPERIMENTAL

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

Device: Nerivio(R) Device

Interventions

Nerivio(R) DeviceDEVICE

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

Intervention group
Usual CareOTHER

Patients will use their usual care to treat pain.

Control group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center - Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PNP-PC Pain Management, Principal Investigator

Study Record Dates

First Submitted

November 6, 2025

First Posted

November 25, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)