- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164823
The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zaragoza, Spain, 50009
- Elena Estebanez de Miguel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medical Taping
Medical taping will be applied as a self-treatment. All participants will be instructed in an indvidual session and will receive a tutorial video to remember the kinesiotaping procedure. 3 band of a special and hypoallergenic tape (Kinematix Tex) will be attached to the abdominal (2 strips) and lower back (1 strip). Patients will be taped for four days. It will start at the beginning of pain associated to the menstruation. |
For the medical taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece.
A tape of 20cm in length will be placed horizontally to the lower back.
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Active Comparator: Analgesic self-medication (OTC)
Participants will use the usual analgesic self-treatment for primary dysmenorrhea.It will start at the beginning of pain associated to the menstruation. They will note the treatment indicating the analgesic and the dosage in a calendar. |
Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in menstrual pain with Visual Analogic Scale (VAS)
Time Frame: 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.
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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
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with Visual Analogic Scale (VAS)
Time Frame: 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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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
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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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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elena Estébanez de Miguel, Universidad de Zaragoza
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI17/157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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