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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Semiconductor embedded body sleeve
DeviceThe active device contains semiconductors embedded into the body sleeve fabric
Placebo Non-Compressive Body Sleeve
DeviceIdentical body sleeve absent of semiconductors
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active DeviceActive comparator 1 intervention
Group B: Placebo DevicePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Participant-Reported Changes in Pain
Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group: Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)
Time frame
6 monthsSecondary outcomes
1
Participant-Reported Changes in Quality of Life
Improvement in health-related quality of life as determined by the Short Form quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-SF) compared to placebo group. Q-LES-Q-SF: Lowest score: 14 (indicating very poor quality of life) Highest score: 70 (indicating very good quality of life)
Time frame
6 months2
Changes in oral medication intake compared to placebo group
As measured by collecting concomitant medication information at baseline and changes throughout participation in the study.
Time frame
6 months3
Changes in Participant Pain Score (SF-MPQ-2)
Changes in participant menstrual pain as determined by menstrual pain questionnaire, Short Form McGill Pain Questionnaire (SF-MPQ-2), compared to placebo group. SF-MPQ-2: Lowest score: 0 (no pain) Highest score: 10 (worst possible pain)
Time frame
6 months4
Changes in participant function in daily life
Changes in participant function/distress as determined by Menstrual Distress Questionnaire (MEDI-Q), compared to placebo group. MEDI-Q: Lowest score: 0 (no distress) Highest score: 5 (very much distress)
Time frame
6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
INCREDIWEAR HOLDINGS, INC.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: