Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms

University of California (UC) Davis

Status: Not yet enrolling

Conditions: Primary Dysmenorrhea (PD); Menstrual Cramps; Primary Dysmenorrhea; Women's Health

Treatments: Device: Placebo Non-Compressive Body Sleeve; Device: Semiconductor embedded body sleeve

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07176780

2264207

Details and patient eligibility

About

This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-reported primary dysmenorrhea during past three menstrual cycles
• Age 18-45 inclusive at the time of consent
• Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
• History of regular menstrual cycles with a usual length of 21 to 35 days
• Willing and able to provide informed consent and adhere to study requirements

Exclusion criteria

• History of neurological conditions, including multiple sclerosis or Parkinson's disease

• Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device

• Self-reported size not available in study device

• Pregnant or planning to become pregnant during the study

• Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:

  1. intrauterine device
  2. oral contraceptives,
  3. contraceptive patch,
  4. implant (Nexplanon),
  5. shot (Depo-Provera),
  6. vaginal ring

• Chronic pain conditions unrelated to primary dysmenorrhea

• Auto-immune or auto-inflammatory diseases

• Has used within the last 90 days or is planning to use nicotine-containing products

• History of metabolic disorders

• Active infection (local or systemic) that, in the opinion of the investigator, would prevent usage of the device

• In the opinion of the investigator, any other criteria or condition that could increase the risk associated with study participation or study treatment or could interfere with the interpretation of study results

• Have taken any investigational drug or used any investigational device within the 30 days prior to consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Active Device

Active Comparator group

Description:

Device embedded with semiconductors

Treatment:

Device: Semiconductor embedded body sleeve

Placebo Device

Placebo Comparator group

Description:

Identical device absent of semiconductors

Treatment:

Device: Placebo Non-Compressive Body Sleeve