Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients: A Nurse Practitioner-Led Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Treatment
时间窗: 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.
次要结局
- Frequency of as needed pain medications(4 weeks)
研究者
Elizabeth Wong
PNP-PC Pain Management, Principal Investigator
Children's Health