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

NCT ID: NCT04164823

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Medical taping

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Analgesic self-medication (OTC)

Intervention Type DRUG

Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medical taping

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 DEVICE

Analgesic self-medication (OTC)

Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elena Estebanez de Miguel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elena Estébanez de Miguel

Role: STUDY_DIRECTOR

Universidad de Zaragoza

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Elena Estébanez de Miguel

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30273684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30348455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30530959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28931978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9308868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22792003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16873033 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI17/157

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.