Signal Relief
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.
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-dr…
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Non-invasive, drug-free flexible wellness patch containing conductive particle arrays
Matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays