Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semiconductor embedded body sleeve
- Placebo Non-Compressive Body Sleeve
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of California, Davis
Lead sponsor
INCREDIWEAR HOLDINGS, INC.
Collaborator
Source ClinicalTrials.gov