A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving at Least 30% Change in NPRS Score
研究概览
简要总结
This pilot study is testing whether a thin, flexible, drug-free patch called the Jovi Patch (powered by Signal Relief) can help reduce general menstrual discomfort (pain and related symptoms during periods).
The patch contains no medication, wires, or batteries. It uses special micro-metal particles that are thought to interact with the body's natural electrical signals related to pain. Researchers will compare an active version of the patch to a look-alike sham (inactive) patch.
About 50 pre-menopausal women ages 18-50 who have menstrual discomfort (pain score greater than 4 on a 0-10 scale) will be randomly assigned to one of two groups:
Active patch group (larger group) Sham patch group
Participants will wear their assigned patch during six menstrual cycles (starting the day before their period begins and continuing through the week of flow). After three cycles, women in the sham group will switch to the active patch for the remaining three cycles so researchers can also look at the effects of switching.
The main question is whether more women using the active patch achieve at least a 30% reduction in their pain scores compared with those using the sham patch. The study will also track changes in how much menstrual symptoms interfere with daily life, use of pain medications, and any side effects (such as skin irritation).
Participation lasts through six menstrual cycles. The overall study is expected to take up to 12 months.
详细描述
This is a pilot, randomized, double-blind, sham-controlled study with a crossover component evaluating the Jovi Patch (powered by Signal Relief) for the management of primary dysmenorrhea-related symptoms (general menstrual discomfort).
Menstrual discomfort is common and can significantly affect quality of life. It is largely driven by prostaglandin-mediated uterine hyper-contractility, leading to pain and associated symptoms such as low back pain, nausea, fatigue, and interference with daily activities. First-line treatments are typically nonsteroidal anti-inflammatory drugs (NSAIDs); non-drug options remain limited.
The Jovi Patch is a thin, flexible, non-invasive, drug-free device that contains no wires or batteries. It incorporates conductive particle arrays (micro-metals) designed to interact with the body's electrical signals associated with pain. The proposed mechanism is that the patch provides a preferential pathway for pain-related electrical signals, thereby reducing the intensity of signals reaching the brain. The patch is applied externally to the lower abdomen and/or lower back and is intended to be worn continuously during the menstrual period (except when showering or swimming).
Approximately 50 pre-menopausal women will be randomized in a 1:3 ratio (active:sham) to wear either the active Jovi Patch or a matching sham patch during six consecutive menstrual cycles. After the first three cycles, participants originally assigned to the sham patch will cross over to the active patch for the remaining three cycles. This design allows evaluation of both parallel-group and within-subject effects.
This pilot study is not powered for definitive efficacy conclusions. It is intended to generate preliminary safety and efficacy data to inform future research and product development. The study is being conducted at Redeemer Health in Meadowbrook, Pennsylvania. Participation lasts through six menstrual cycles; the overall study is expected to take up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal female subjects aged 18 -50 years.
- •Currently seeking treatment for general menstrual discomfort
- •NPRS scale score > 4 at baseline.
- •Able and willing to provide informed consent in English without the assistance of an interpreter.
排除标准
- •Receiving other investigational agents or on another clinical trial.
- •Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device.
- •Known to be pregnant, or plan to become pregnant in the next 6 months
- •Current Jovi/Signal Relief users
研究组 & 干预措施
Active Jovi Patch
Participants receive the active Jovi Patch (powered by Signal Relief), a non-invasive, drug-free flexible wellness patch containing conductive particle arrays. The patch is worn during six consecutive menstrual cycles (or three cycles if crossing over from sham).
干预措施: Jovi Patch (Device)
Sham Patch
Participants receive a matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays. After three cycles, these participants cross over to the active Jovi Patch for the remaining three cycles.
干预措施: Sham Patch (Device)
结局指标
主要结局
Proportion of Participants Achieving at Least 30% Change in NPRS Score
时间窗: Baseline to end of treatment (after 6 menstrual cycles)
Proportion of participants who achieve at least a 30% change in their Numeric Pain Rating Scale (NPRS) score (0 = no pain, 10 = worst imaginable pain) from baseline to the end of treatment.
次要结局
未报告次要终点