Clinical trial NCT07022106: Comparison of Different Physiotherapy Techniques in Dysmenorrhea
Official title: Comparison of Myofascial Release and Kinesiotaping Techniques in the Management of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: primary dysmenorrhea
kinesiotape
myofascial release
pain
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is investigating the effects of myofascial release technique \& kinesiotape in managing dysmenorrhea

Detailed description: Dysmenorrhea is a common gynecological disorder characterized by painful menstruation manifested by severe cramps in the lower abdomen. According to the World Health Organization (WHO) data, it affects 50-90% of women globally (10-20% of cases have severe symptoms); recent epidemiological studies in Türkiye show that this rate is significantly high (75-85%).Dysmenorrhea is divided into two types: primary dysmenorrhea (PD) and secondary dysmenorrhea. PD is painful menstruation without any underlying pathological condition. The main goal of dysmenorrhea treatment is to significantly improve the patient's well-being and quality of life (QoL) by effectively relieving pain and relieving symptoms by targeting physiological mechanisms. There are various physiotherapy methods that can be used to reduce this pain, such as transcutaneous electrical nerve stimulation (TENS), cryotherapy, myofascial release therapy (MRT), and kinesiology taping (KT).

This single-blind randomized controlled trial will investigate the acute therapeutic effects of Myofascial Release Technique (MRT) versus Kinesio Taping (KT) in 46 females aged 18-30 years with PD. Participants will be randomised into Group 1 (MRT; n = 23) or Group 2 (KT; n = 23), receiving a single intervention session during their most painful menstrual day

All participants will be asked to fill out 3 forms, namely a sociodemographic questionnaire covering age, height, BMI, age at menarche and duration of menstruation, a Visual Analog Scale (VAS) to assess pain level and a Patient Reported Outcomes Measurement System (PROMIS-29 Profile v2.0) to measure quality of life (QoL) at 3 time points (pre-intervention, 8 hours after intervention ,and 3-5 weeks post intervention (at the first menstrual cycle after intervention).

Statistical analyses will be conducted by using SPSS 27.0 (IBM Corp.), with a priori power analysis confirming 95% power (α = 0.05; G\*Power v3.1.9.7). Data normality will be verified via the Shapiro-Wilk test. Independent Samples t-tests will compare interventional effects between groups, while one-way ANOVA (with LSD post-hoc tests) will analyze multi-point QoL changes. Paired Samples t-tests will evaluate within-group temporal changes (pre vs. post-intervention).

Eligibility criteria: Inclusion Criteria:

Diagnosis of primary dysmenorrhea, Moderate-to-severe pain during menstrual days 1-3, Regular menstrual cycles for past 6 months

Exclusion Criteria:

Secondary gynaecological conditions, Current use of pain medications, History of pregnancy

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions)
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0)
timeFrame: Before the interventions, after 8 hours from the interventions, & 3-5 weeks post-intervention (first menstrual cycle after interventions)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Gizem Ergezen Şahin, PhD
role: STUDY_CHAIR
References: