Primary Dysmenorrhea Clinical Trial
Official title:
The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea
NCT number | NCT04164823 |
Other study ID # | PI17/157 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | May 31, 2020 |
Verified date | June 2020 |
Source | Universidad de Zaragoza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea
Status | Completed |
Enrollment | 15 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Women presenting menstrual pain, 4 or more in VAS. - 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 - Ability to complete questionnaires in Spanish. 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 or in lumbar region - Use or abuse of drugs or alcohol |
Country | Name | City | State |
---|---|---|---|
Spain | Elena Estébanez de Miguel | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Universidad de Zaragoza |
Spain,
Campbell MA, McGrath PJ. Use of medication by adolescents for the management of menstrual discomfort. Arch Pediatr Adolesc Med. 1997 Sep;151(9):905-13. — View Citation
Choi JH. Effects of kinesio taping and hot packs on premenstrual syndrome in females. J Phys Ther Sci. 2017 Sep;29(9):1514-1517. doi: 10.1589/jpts.29.1514. Epub 2017 Sep 15. — View Citation
Espí-López GV, Inglés M, Ferrando AC, Serra-Añó P. Effect of Kinesio taping on clinical symptoms in people with fibromyalgia: A randomized clinical trial. J Back Musculoskelet Rehabil. 2019;32(4):561-567. doi: 10.3233/BMR-171100. — View Citation
Grandi G, Ferrari S, Xholli A, Cannoletta M, Palma F, Romani C, Volpe A, Cagnacci A. Prevalence of menstrual pain in young women: what is dysmenorrhea? J Pain Res. 2012;5:169-74. doi: 10.2147/JPR.S30602. Epub 2012 Jun 20. — View Citation
Lu Z, Li X, Chen R, Guo C. Kinesio taping improves pain and function in patients with knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2018 Nov;59:27-35. doi: 10.1016/j.ijsu.2018.09.015. Epub 2018 Sep 28. Review. — View Citation
Macedo LB, Richards J, Borges DT, Melo SA, Brasileiro JS. Kinesio Taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy. 2019 Mar;105(1):65-75. doi: 10.1016/j.physio.2018.07.005. Epub 2018 Jul 26. — View Citation
O'Connell K, Davis AR, Westhoff C. Self-treatment patterns among adolescent girls with dysmenorrhea. J Pediatr Adolesc Gynecol. 2006 Aug;19(4):285-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in menstrual pain with Visual Analogic Scale (VAS) | VAS is a method of representing subjects' pain on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of pain' and 10 means 'a very high degree of pain | Participants will be followed for 6 menstrual cycles. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment in each menstrual cycle. | |
Secondary | Patient satisfaction with Visual Analogic Scale (VAS) | Participants will note the self-care applied to relief menstrual pain indicating the VAS is a method of representing subjects' satisfaction with treatment on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of satisfaction with treatment' and 10 means 'a very high degree of satisfaction with treatment | Participants will be followed for 6 menstrual cycles. Evaluations will be performed at the end of each treatment, when menstrual pain disappears (4-5 days after the beginning of the menstrual bleeding). |
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