A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea
Phase 3
- Conditions
- Dysmenorrhea
- Interventions
- Device: shamDevice: I RUNE
- Registration Number
- NCT01662934
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
- Detailed Description
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 118
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham sham Using not functioning device Experimental I RUNE Using functioning device
- Primary Outcome Measures
Name Time Method Change of VAS before and after application of machine Immediately before application of machine and 20minutes after application of machine Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
- Secondary Outcome Measures
Name Time Method BPI score 2nd day of menstrual cycle Brief Pain Inventory score
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam Si, Gyenggi Do, Korea, Republic of