Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semiconductor embedded body sleeve, Placebo Non-Compressive Body Sleeve.
- Who it may be relevant to
- Registry conditions: Primary Dysmenorrhea, Primary Dysmenorrhea (PD), Menstrual Cramps, Women's Health. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Semiconductor Embedded Wearable Sleeve on the Treatment and Mitigation of Primary Dysmenorrhea Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Overview
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
- Device Semiconductor embedded body sleeve
The active device contains semiconductors embedded into the body sleeve fabric - Device Placebo Non-Compressive Body Sleeve
Identical body sleeve absent of semiconductors
Primary outcome measures
- Participant-Reported Changes in Pain [Time frame: 6 months]
Secondary outcome measures (5)
- Participant-Reported Changes in Quality of Life [Time frame: 6 months]
- Changes in oral medication intake compared to placebo group [Time frame: 6 months]
- Changes in Participant Pain Score (SF-MPQ-2) [Time frame: 6 months]
- Changes in participant function in daily life [Time frame: 6 months]
- Changes in menstrual symptom duration [Time frame: 6 months]
Eligibility criteria
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:
- intrauterine device
- oral contraceptives,
- contraceptive patch,
- implant (Nexplanon),
- shot (Depo-Provera),
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07176780 · 2264207