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

NCT04164823 | Completed

• 1 other identifier: PI17/157
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Taping; Pain

Outcome Measures

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

  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 Outcomes (1)

• Patient satisfaction with Visual Analogic Scale (VAS)

  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).

Study Arms (2)

Medical Taping

EXPERIMENTAL

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.

Device: Medical taping

Analgesic self-medication (OTC)

ACTIVE COMPARATOR

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.

Drug: Analgesic self-medication (OTC)

Interventions

Medical taping 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.

Medical Taping

Analgesic self-medication (OTC) DRUG

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

Analgesic self-medication (OTC)

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, 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.

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 or in lumbar region
• Use or abuse of drugs or alcohol

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Elena Estébanez de Miguel

Zaragoza, 50009, Spain

Location

Related Publications (7)

• 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.

  PMID: 30273684 BACKGROUND

• 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.

  PMID: 30348455 BACKGROUND

• 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.

  PMID: 30530959 BACKGROUND

• 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.

  PMID: 28931978 BACKGROUND

• 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.

  PMID: 9308868 BACKGROUND

• 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.

  PMID: 22792003 BACKGROUND

• 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.

  PMID: 16873033 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elena Estébanez de Miguel

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: December 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)