Effectiveness of Medical Taping Concept in Primary Dysmenorrhea

NCT02114723 | Completed

• 1 other identifier: DPC-MITR-01-1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms most frequently described in primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Keywords

Mediacal Taping concept; Neuromuscular bandage; Physiotherapy techniques; Kinesio Tape

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths

Secondary Outcomes (1)

• Number of analgesics requiring during menstruation

  Participants will be followed for 4 menstrual cycles, an expected average of 5 mounths

Other Outcomes (1)

• Quality of live

  before/after intervention (5 mounths)

Study Arms (2)

Medical Taping Concept

ACTIVE COMPARATOR

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

Device: Medical Taping Concept

Cross tape

PLACEBO COMPARATOR

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)

Device: Medical Taping Concept

Interventions

Medical Taping Concept DEVICE

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

Also known as: Cure Tape®, Kinesio Tape®, Kinesiotape Akraven, Kinesio® Tex, BB Tape (Bio balance tape), BB Lattice Tape

Cross tape; Medical Taping Concept

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Universidad Miguel Hernández de Elche

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (6)

• 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.

  PMID: 24259847 RESULT

• 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

  RESULT

• Garzón-Rodríguez, C. Analgessic effectiveness of Kinesio Taping versus abdominal massage in women with dysmenorrhea. Cuest. fisioter.42 (3): 302-311, 2013

  RESULT

• 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.

  PMID: 15493566 RESULT

• 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.

  PMID: 2179780 RESULT

• 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.

  PMID: 26564807 DERIVED

Related Links

• Kinesio Taping® Association International

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• María I Tomás-Rodríguez, PT, MSC

  Universidad Miguel Hernández de Elche

  PRINCIPAL INVESTIGATOR

• José V Toledo-Marhuenda, PhD

  Universidad Miguel Hernández de Elche

  STUDY DIRECTOR

• Vicente F Gil-Guillén, MD, PhD

  Universidad Miguel Hernández de Elche

  STUDY DIRECTOR

• Antonio Palazón-Bru, MPH

  Universidad Miguel Hernández de Elche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSC

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 15, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

ES (1)