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| Name | Class |
|---|---|
| Theranica | INDUSTRY |
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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:
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:
All participants in the "control group" will:
All participants in the "intervention" group will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients with AMPS in the control group will use their usual practices to control pain. |
|
| Intervention group | Experimental | Patients in the experimental group will use the Nerivio(R) device once every 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio(R) Device | Device | Patients will use the Nerivio(R) device once every 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center - Dallas | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual Care | Other | Patients will use their usual care to treat pain. |
|
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 | 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 |