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CompletedNCT03290066Updated Jul 31, 2019

Effectiveness of Kinesiotaping in Primary Dysmenorrhea

An interventional study of kinesiotape and Usual care in Primary Dysmenorrhea, sponsored by Universidad de Zaragoza. Completed at 1 site in Spain. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study summary

Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

Read the 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.

Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common cause of absenteeism and reduced quality of life in women.

Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms.

First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some women have contraindications to these treatments. Consequently, it´s necessary to study alternative treatments to drug treatments. Alternative treatments like heat, massage therapy, acupuncture also are used.

The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s. It is water resistant and retains its properties up to 5 days.

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.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Primary Dysmenorrhea
  • Kinesio Taping
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Kinesiotape

    Kinesiotape 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 , ıt will start at the beginning of the menstruation.

    Device: kinesiotape

  • Active comparator
    Usual care

    Participants will use the usual self-care for primary dysmenorrhea. It will start at the beginning of the menstruation. They will note the treatment indicating the dosage in a calendar.

    Other: Usual care

Interventions

  • Devicekinesiotape

    For the Kinesio 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.

  • OtherUsual care

    Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).

    Also known as: self-care

05

What researchers measure

Primary outcomes

  1. 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.'

    Time frame: Participants will be followed for 2 menstrual cycles, an expected average of 3 months. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment

Secondary outcomes

  1. 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.'

    Time frame: Participants will be followed for 2 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).

06

Study locations

1 site
  • Elena Estebanez de Miguel
    Zaragoza, 50009, Spain
07

Registry details

Key details

Study ID
NCT03290066
Lead sponsor
Universidad de Zaragoza
Responsible party
Elena Estebanez de Miguel (PhD, Universidad de Zaragoza) — Principal investigator
First posted
Sep 21, 2017
Start date
Sep 1, 2017
Primary completion
Jan 30, 2018
Completion
Apr 30, 2018
Last update
Jul 31, 2019

Study contacts

Elena Estebanez de Miguel, PhD
principal investigator · Universidad de Zaragoza

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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