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The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Medical taping
Analgesic self-medication (OTC)
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, Taping, Pain

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Elena Estébanez de Miguel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medical Taping

Analgesic self-medication (OTC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2019
Last Updated
June 8, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04164823
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Primary Dysmenorrhea, Taping, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Taping
Arm Type
Experimental
Arm Description
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.
Arm Title
Analgesic self-medication (OTC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medical taping
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Analgesic self-medication (OTC)
Intervention Description
Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).
Primary Outcome Measure Information:
Title
Change in menstrual pain with Visual Analogic Scale (VAS)
Description
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
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.
Secondary Outcome Measure Information:
Title
Patient satisfaction with Visual Analogic Scale (VAS)
Description
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
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Estébanez de Miguel
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Study Director
Facility Information:
Facility Name
Elena Estébanez de Miguel
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30273684
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.
Results Reference
background
PubMed Identifier
30348455
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.
Results Reference
background
PubMed Identifier
30530959
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.
Results Reference
background
PubMed Identifier
28931978
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.
Results Reference
background
PubMed Identifier
9308868
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.
Results Reference
background
PubMed Identifier
22792003
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.
Results Reference
background
PubMed Identifier
16873033
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.
Results Reference
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The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea

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