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The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Using not functioning device |
|
| Experimental | Experimental | Using functioning device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I RUNE | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of VAS before and 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 | Immediately before application of machine and 20minutes after application of machine |
| Measure | Description | Time Frame |
|---|---|---|
| BPI score | Brief Pain Inventory score | 2nd day of menstrual cycle |
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Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyenggi Do | 463707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26340453 | Derived | Lee B, Hong SH, Kim K, Kang WC, No JH, Lee JR, Jee BC, Yang EJ, Cha EJ, Kim YB. Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:58-63. doi: 10.1016/j.ejogrb.2015.08.020. Epub 2015 Aug 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2013 | |
| Reset | Jul 1, 2013 | |
| Release | Oct 29, 2017 |
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| sham |
| Device |
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|
| Reset | Aug 1, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2013 | Jul 1, 2013 | |||
| Oct 29, 2017 | Aug 1, 2018 |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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