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NCT Number: NCT07249931

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

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).

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Key information

Conditions

Amplified Musculoskeletal Pain Syndrome (AMPS) Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Medical Center - Dallas

Dallas, Texas, 75235, United States

Location contact

Catherine Clark, DNP, RN, ACCNS-P

CONTACT

[email protected]

Elizabeth Wong, MSN, APRN, CPNP-PC, PMGT-BC

CONTACT

[email protected]

214-793-2036

Kathleen Ellis, PhD, CCRN, CNE

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerivio(R) Device

Device

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

Usual Care

Other

Patients will use their usual care to treat pain.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Children's Health

Other

Collaborators

  • Theranica

Registry information

Official study title

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

Acronym: Nerivio

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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