Primary Dysmenorrhea Clinical Trial
Official title:
Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
Verified date | November 2014 |
Source | Universidad Miguel Hernandez de Elche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
Status | Completed |
Enrollment | 129 |
Est. completion date | September 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Women presenting menstrual pain grade 2-3 according to the classification of the severity of primary dysmenorrhea Andersch and Milsom. - Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea - Not have been diagnosed with secondary dysmenorrhea - Regular menstrual cycles (cycle typical range of 21 to 35 days) - Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills - Nulliparous Exclusion Criteria: - Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10); - Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days); - Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills. - Women who suffer from diseases diagnosed added - Women to which it has undergone a surgical procedure for the treatment - Provide skin lesions in the abdominal wall - Use or abuse of drugs or alcohol - Body mass index (BMI) between> 15.99 kg/m2 (maximum value of underweight according to WHO) and <25.00 kg m2 (maximum overweight according to WHO) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Miguel Hernández de Elche | Sant Joan D'Alacant | Alicante |
Lead Sponsor | Collaborator |
---|---|
Universidad Miguel Hernandez de Elche |
Spain,
Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45. — View Citation
Dawood MY, Ramos J. Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen. Obstet Gynecol. 1990 Apr;75(4):656-60. — View Citation
Garzón-Rodríguez, C. Analgessic effectiveness of Kinesio Taping versus abdominal massage in women with dysmenorrhea. Cuest. fisioter.42 (3): 302-311, 2013
Lim C, Park Y, Bae Y. The effect of the kinesio taping and spiral taping on menstrual pain and premenstrual syndrome. J Phys Ther Sci. 2013 Jul;25(7):761-4. doi: 10.1589/jpts.25.761. Epub 2013 Aug 20. — View Citation
Wefers c, Pijnappel H.F, Stolwijk N.M. Effect of Cure Tape® on menstrual pain in women with primary dysmenorrhea. Ned Tijdscr Fysiother 119(6): 193-197, 2009
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of live | Quality of live Questionnaire Euroquol-5D (EQ-5D) | before/after intervention (5 mounths) | No |
Primary | Pain NRS (numeric rating scale) | Evaluations will be performed before, just after, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment. It will be measured in abdominal area, low back, lower limb and head. | Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths | No |
Secondary | Number of analgesics requiring during menstruation | Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths | No |
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