NCT07145424

Brief Summary

Purpose: Dysmenorrhea is one of the most common causes of disability in women's health worldwide. It affects women's daily activities and negatively affects their social life. It increases healthcare costs and constitutes a significant burden for both women and society. Therefore, interventions to improve dysmenorrhea are needed. The aim of the study is to examine the effect of kinesio taping (KT) intervention on pain, muscle strength, functional disability, physical activity level, and quality of life. Methods: Participants with primary dysmenorrhea were divided into kinesio taping (KT) and control (C) groups. The KT group underwent consecutive taping for 12 days starting from the premenstrual week. Trunk muscle strength evaluation, visual analogue scale (VAS), the pressure pain threshold, menstrual distress questionnaire (MDQ), SF-36 quality of life scale, Oswestry disability index (ODI), international physical activity questionnaire (IPAQ) were used as outcome measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

August 19, 2025

Last Update Submit

August 20, 2025

Conditions

Keywords

dysmenorrheaquality of liferehabilitationpain

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale

    The Visual Analogue Scale (VAS) was used to evaluate the intensity of menstrual pain experienced by participants.It is a valid, reliable, and easily understandable scale that has been employed in research to assess the severity of primary dysmenorrhea. VAS is widely recognized as the most common quantitative measure for assessing the intensity of pain, where "0" represents no pain and "10" represents the most severe pain experienced .

    from baseline to 4th week

  • Pressure pain threshold assessment

    Trigger points, whether active or latent, can contribute to increased muscle tension and subsequently lead to musculoskeletal pain. The pressure pain threshold at trigger points in the lumbar region was assessed using an analog algometer. Participants were instructed to indicate when they first experienced pain, and the corresponding pressure value was documented .

    from baseline to 4th week

  • Muscle strength measurement

    A handheld dynamometer (Lafayette Instrument Company, Lafayette®, Lafayette, LA, USA) was used to evaluate the maximal muscle strength of the trunk muscles. This device represents a cost-effective and portable tool for assessing muscular strength, which is commonly employed in clinical settings due to its high reliability and validity relative to more sophisticated laboratory-based dynamometers. Participants were instructed to exert maximum muscle force against the fixed dynamometer held by the therapist, and their strength was measured. To assess trunk flexor strength, participants were positioned in supine with knees slightly bent, arms at their sides, and head in neutral. The dynamometer was placed on the midpoint of the sternum, and participants were asked to lift their scapulae from the floor. Trunk extensor strength was evaluated with participants in the prone position.

    from baseline to 4th week

Secondary Outcomes (4)

  • Menstrual distress questionnaire (MDQ)

    from baseline to 4th week

  • SF-36 quality of life scale

    from baseline to 4th week

  • Oswestry disability index

    from baseline to 4th week

  • International physical activity questionnaire (IPAQ)

    From baseline to 4th week

Study Arms (2)

kinesio taping group

EXPERIMENTAL

kinesio taping was applied to the KT group taping was initiated during the participants' second menstrual cycle

Other: kinesio taping group

control

NO INTERVENTION

This group only received assessments.

Interventions

The original Kinesio Tape (Kinesio Tex Classic Tape) was used for taping by a physiotherapist with 15 years of experience in the field. The tape was cut into an I-shape and applied to the lower abdominal and lumbo-sacral regions where the participants experienced pain, 10 days prior to the anticipated start of menstruation (Figure 2). The tapes were renewed after four days. This procedure was performed three times and the total taping period was completed as 12 days. The tapes were removed on the third day of menstruation and all outcome measurements were performed again for the post intervention measurements

kinesio taping group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females who are currently going through monthly menstruation cycles (21-35 days)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-30
  • No hormonal contraception or intrauterine devices in the last 3 months
  • Regular menstruation (every 21-35 days) for the last 6 months
  • Pain score of 5 or more according to VAS.

You may not qualify if:

  • Gynecological diseases
  • Chronic systemic diseases
  • Pregnancy or multiparousus
  • Psychotherapeutic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaDysmenorrheaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic ProcessesPelvic Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to their group assignments. Outcome assessors were not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 28, 2025

Study Start

March 1, 2018

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations