Amplified Musculoskeletal Pain Syndrome (AMPS)NerivioNCT07249931
Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients
A study testing Nerivio(R) Device in people with Amplified Musculoskeletal Pain Syndrome (AMPS), run by Children's Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Amplified Musculoskeletal Pain Syndrome (AMPS)
- What is being tested?
- Nerivio(R) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Medical Center - Dallas
Dallas, Texas, 75235
Elizabeth Wong, MSN, APRN, CPNP-PC, PMGT-BC, 214-793-2036, Elizabeth.Wong@Childrens.com
Catherine Clark, DNP, RN, ACCNS-P, Catherine.Clark@Childrens.com
About this study
Official title: 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?
Read more
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).
- Being tested
- Nerivio(R) Device, Usual Care
- Keywords
- Amplified Musculoskeletal Pain Syndrome (AMPS), Pediatrics
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio(R) DeviceDevice
Patients will use the Nerivio(R) device once every 48 hours.
Usual CareOther
Patients will use their usual care to treat pain.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients with AMPS in the control group will use their usual practices to control pain. Receives: Other: Usual Care |
| Intervention group | Experimental | Patients in the experimental group will use the Nerivio(R) device once every 48 hours. Receives: Device: Nerivio(R) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment
Measure change from baseline in pain scores to reported pain scores after using the Nerivio device for pediatric patients with AMPS.
Measured: over a four-week intervention period.
Secondary outcomes (1)
Frequency of as needed pain medications
Evaluate frequency in PRN medications for pain in both the participants using the Nerivio device and those with only the traditional treatment plan.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amplified Musculoskeletal Pain Syndrome (AMPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Health
- Sponsor type
- University, hospital or other
- Collaborators
- Theranica
- Responsible party
- Principal investigator, Elizabeth Wong, Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249931
- Sponsor's protocol ID
- Nerivio Protocol
- Acronym
- Nerivio
- Status last verified
- Nov 2025
- First submitted
- 6 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients: A Nurse Practitioner-Led Pilot Study
- ClinicalTrials.gov ID
- NCT07249931
- Acronym / sponsor ID
- Nerivio / Nerivio Protocol
- Keywords
- Amplified Musculoskeletal Pain Syndrome (AMPS), Pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's HealthUniversity, hospital or other
- Collaborators
- Theranica
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Usual CarePatients with AMPS in the control group will use their usual practices to control pain. |
| Intervention group | Experimental | Device: Nerivio(R) DevicePatients in the experimental group will use the Nerivio(R) device once every 48 hours. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerivio(R) DevicePatients will use the Nerivio(R) device once every 48 hours. | Device | Intervention group |
| Usual CarePatients will use their usual care to treat pain. | Other | Control group |
Primary outcome
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.
1 secondary outcome
Frequency of as needed pain medications
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Amplified Musculoskeletal Pain Syndrome (AMPS)
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Two Point Discrimination
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio(R) Device in people with Amplified Musculoskeletal Pain Syndrome (AMPS), run by Children's Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment (time frame: over a four-week intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.