Clinical trial NCT04164823: The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea
Official title: The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Taping
Pain
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

Detailed description: Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.

About 50-90% of the women experience menstrual pain, and approximately 15% of them suffer from a severe level of pain It is a common cause of absenteeism and reduced quality of life in women.

From 21% to 96% of women with menstrual pain, reported to practice self-treatment either by pharmacological or nonpharmacological interventions. However, there are adverse events associated with the use of these drugs, including stomach ache, diarrhea, nausea, cutaneous reactions, liver or kidney damage or cardiovascular risk after discontinuing medication . Therefore, many patients with menstrual pain usually seek complementary and alternative techniques.

Medical taping concept is an alternative treatment that use elastic adhesive tape, which is applied to the patient's skin under tension.

It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.

Eligibility criteria: 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

Primary outcomes:
measure: Change in menstrual pain with Visual Analogic Scale (VAS)
timeFrame: 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 outcomes:
measure: Patient satisfaction with Visual Analogic Scale (VAS)
timeFrame: 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).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Elena Estébanez de Miguel
Study officials:
affiliation: Universidad de Zaragoza
name: Elena Estébanez de Miguel
role: STUDY_DIRECTOR
References:
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.
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.
citation: Espi-Lopez GV, Ingles M, Ferrando AC, Serra-Ano 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.
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.
citation: 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. doi: 10.1001/archpedi.1997.02170460043007.
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.
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. doi: 10.1016/j.jpag.2006.05.004.