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

Conditions

• Amplified Musculoskeletal Pain Syndrome (AMPS)

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Dec 1, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Control group
  Patients with AMPS in the control group will use their usual practices to control pain.
• Experimental: Intervention group
  Patients in the experimental group will use the Nerivio(R) device once every 48 hours.

Primary Outcome Measure

Treatment [ Time Frame: over a four-week intervention period. ]

Locations (1)

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