Effectiveness of Kinesiotaping in Primary Dysmenorrhea

NCT03290066 | Completed

• 1 other identifier: UZaragoza
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Kinesio Taping

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 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 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).

Study Arms (2)

Kinesiotape

ACTIVE COMPARATOR

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

Usual care

ACTIVE COMPARATOR

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

kinesiotape DEVICE

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.

Kinesiotape

Usual care OTHER

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

Also known as: self-care

Usual care

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 Estebanez de Miguel

Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

Athletic Tape; Self Care

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elena Estebanez de Miguel, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

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: PhD

Model Details: Each woman will be assigned to a sequence of treatments, including two treatments (kinesiotape and usual dysmenorrhea treatment). The sample will be randomized in two different sequences of treatments (kinesiotape/usual treatment or usual treatment/kinesiotape)

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 21, 2017
• Study Start: September 1, 2017
• Primary Completion: January 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

ES (1)