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Effectiveness of Medical Taping Concept in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Medical Taping Concept
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Dysmenorrhea focused on measuring Mediacal Taping concept, Neuromuscular bandage, Physiotherapy techniques, Kinesio Tape

Eligibility Criteria

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

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)

Sites / Locations

  • Universidad Miguel Hernández de Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Medical Taping Concept

Cross tape

Arm Description

3 band of a special and hypoallergenic tape, called Cure Tape ® (2 strips of 12 x 5 cm and 1 strip of 20 cm x 5 cm) are attached to the abdominal and lower back. One piece of 12 cm in length is applied right from below the navel and reached to where the pubic hair below, and another piece of 12 cm in length is applied to make a cross shape with the first piece (inside 11-12 dermatomes area). The piece of 20cm in length is placed horizontally to the lower back. The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears

Two pieces of special and squared tape of 2.5 x 2 cm called Cross Tape ® are attached to the external side of the thigh at the hip joint area (outside 11-12 dermatomes area)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of analgesics requiring during menstruation

Full Information

First Posted
April 7, 2014
Last Updated
November 11, 2014
Sponsor
Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT02114723
Brief Title
Effectiveness of Medical Taping Concept in Primary Dysmenorrhea
Official Title
Assessment of Mediacal Taping Concept Self-applied, in the Treatment of Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.
Detailed Description
The aim of this study is to assess the analgesic efficacy of self-applied Medical Taping Concept in the treatment of primary dysmenorrhea . To evaluate this effect, a total of 128 students from the University Miguel Hernández , with the following inclusion criteria, participated in this study: history of menstrual pain, aged between 18 and 39 years who have performed a gynecological check in the last 18 months and who have been diagnosed with any kind of primary dysmenorrhea. A preliminary survey to identify valid students was made. Thereafter the participants were separated into two different groups (intervention group and placebo group) in order to request the completion of three questionnaires about the characteristics of menstrual pain and other demographic data for the next two menstrual cycles before the intervention. One survey included a graphic scale so the students could mark the start and the end of the symptoms associated with the menstrual cycle. After that the principal researcher will interviewed with the participants to show them the correct auto-application of the menstrual bandage and placebo. Each students group will receive a triptych with information and pictures to the correct application of the adhesive strips. Finally, during two new menstrual cycles, the participants will answer the same questionnaires to assess symptoms and menstrual pain while being worn adhesive strips (3 pieces of Kinesio tape - 20 cm x 5 cm Tape Cure ®-, applied to the abdominal and lower back, in the intervention group; 2 pieces of Cross Tape ® 2.5 cm x 2 cm -, in the hip joint, in the placebo group. Participants may do personal hygiene during the days of the menstrual cycle with their adhesives strips placed on oneself. The size sample will be 128 girls. Differences will be contrasted in comparison of means (quantitative improvement, with an ANOVA) to evaluate the intervention. 18 girls were randomly chosen to obtain an estimation of the contrast parameters considered (means and standard variations). With this size sample and a significance of 5%, the investigators will have a power for the total sample for the contrasts of 80%. To describe the variables, the investigators will use frequencies (absolute and relative) for the qualitative variables. For the quantitative variables, the investigators will use means plus standard variations. To verify the homogeneity of the randomization the investigators will use tests based on the X2 (Pearson or Fisher) and t-test. The same procedure will be used to verify that the participants who quit the study have similar characteristics as those who remain. The improvement will be analyzed quantitatively using ANOVA test. Dependent variable: pain after the intervention. Independent variables: pain before the intervention, changes in pharmacological therapy and intervention group. In the event of significant differences in the ANOVA models the investigators will use the Tukey post-hoc test, in order to determine where the differences exist between the two groups. Qualitatively, the investigators will assess the improvement by calculating indicators of clinical relevance: relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR), and number needed to treat (NNT). All the analyses will be made at a significance of 5%. The confidence intervals (CI) will be calculated for the most relevant parameters. The analyses will be done using IBM SPSS Statistics 19.0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Mediacal Taping concept, Neuromuscular bandage, Physiotherapy techniques, Kinesio Tape

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Taping Concept
Arm Type
Active Comparator
Arm Description
3 band of a special and hypoallergenic tape, called Cure Tape ® (2 strips of 12 x 5 cm and 1 strip of 20 cm x 5 cm) are attached to the abdominal and lower back. One piece of 12 cm in length is applied right from below the navel and reached to where the pubic hair below, and another piece of 12 cm in length is applied to make a cross shape with the first piece (inside 11-12 dermatomes area). The piece of 20cm in length is placed horizontally to the lower back. The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears
Arm Title
Cross tape
Arm Type
Placebo Comparator
Arm Description
Two pieces of special and squared tape of 2.5 x 2 cm called Cross Tape ® are attached to the external side of the thigh at the hip joint area (outside 11-12 dermatomes area)
Intervention Type
Device
Intervention Name(s)
Medical Taping Concept
Other Intervention Name(s)
Cure Tape®, Kinesio Tape®, Kinesiotape Akraven, Kinesio® Tex, BB Tape (Bio balance tape), BB Lattice Tape
Intervention Description
The material used is a lengthways tape bandage of cotton with elastic properties, provided with a layer of anti-allergic adhesive in one of its sides that does not contain latex. This layer of glue is applied according to a special pattern so as to allow adequate transpiration. The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears
Primary Outcome Measure Information:
Title
Pain NRS (numeric rating scale)
Description
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.
Time Frame
Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Secondary Outcome Measure Information:
Title
Number of analgesics requiring during menstruation
Time Frame
Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths
Other Pre-specified Outcome Measures:
Title
Quality of live
Description
Quality of live Questionnaire Euroquol-5D (EQ-5D)
Time Frame
before/after intervention (5 mounths)

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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María I Tomás-Rodríguez, PT, MSC
Organizational Affiliation
Universidad Miguel Hernández de Elche
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José V Toledo-Marhuenda, PhD
Organizational Affiliation
Universidad Miguel Hernández de Elche
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vicente F Gil-Guillén, MD, PhD
Organizational Affiliation
Universidad Miguel Hernández de Elche
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonio Palazón-Bru, MPH
Organizational Affiliation
Universidad Miguel Hernández de Elche
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad Miguel Hernández de Elche
City
Sant Joan D'Alacant
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24259847
Citation
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.
Results Reference
result
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
Results Reference
result
Citation
Garzón-Rodríguez, C. Analgessic effectiveness of Kinesio Taping versus abdominal massage in women with dysmenorrhea. Cuest. fisioter.42 (3): 302-311, 2013
Results Reference
result
PubMed Identifier
15493566
Citation
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.
Results Reference
result
PubMed Identifier
2179780
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.
Results Reference
result
PubMed Identifier
26564807
Citation
Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.
Results Reference
derived
Links:
URL
http://www.kinesiotaping.com/
Description
Kinesio Taping® Association International
URL
http://www.aevnm.com/
Description
Spanish Association of Neuromuscular Bandage.

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Effectiveness of Medical Taping Concept in Primary Dysmenorrhea

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