Menstrual Cramps, Primary Dysmenorrhea, Primary Dysmenorrhea (PD), Women's Health
Conditions
Keywords
Menstrual Cramps, Dysmenorrhea, Primary Dysmenorrhea, Women's Health
Brief summary
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.
Interventions
DEVICESemiconductor embedded body sleeve
The active device contains semiconductors embedded into the body sleeve fabric
DEVICEPlacebo Non-Compressive Body Sleeve
Identical body sleeve absent of semiconductors
Sponsors
University of California, Davis
INCREDIWEAR HOLDINGS, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Changes in Pain | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Changes in Quality of Life | 6 months | 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) |
| Changes in oral medication intake compared to placebo group | 6 months | As measured by collecting concomitant medication information at baseline and changes throughout participation in the study. |
| Changes in Participant Pain Score (SF-MPQ-2) | 6 months | 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) |
| Changes in participant function in daily life | 6 months | 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) |
| Changes in menstrual symptom duration | 6 months | Changes in menstrual symptom duration compared to placebo group as reported by participants at each menstrual cycle. |
Contacts
CONTACTUC Davis Health Ob/Gyn Research
Outcome results
None listed