Comparison of Different Physiotherapy Techniques in Dysmenorrhea

NCT ID: NCT07022106

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-10-01

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. Recent epidemiological studies indicate a global prevalence of 50-90% among women (10-20% with severe symptoms); in Türkiye, studies show a prevalence of 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).

Conditions

Dysmenorrhea Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kinesiotape (KT) Group

Participants in this arm will receive Kinesio Taping applied to the lower abdomen and lumbar region using a 3-Tape Sensory Modulation Technique to modulate pain and fascial tension.

Group Type: EXPERIMENTAL

Kinesiotape (KT) Group

Intervention Type: OTHER

Kinesio Taping (KT) Intervention

Description:

Participants will receive a standardized 3-tape sensory modulation technique using Kinesiotape, applied to the abdomen and sacrum to target fascial tension and visceral pain in primary dysmenorrhea.

Procedure:

Abdominal Application (Two Tapes, 0% Stretch):

Horizontal Tape: Placed between the iliac crests (lower abdomen) to reduce fascial tension.

Vertical Tape: Applied from the navel to the pubic symphysis to modulate visceral pain signaling.

Sacral Application (One Tape, 15-25% Stretch):

Horizontal Tape: Anchored across the S2-S4 vertebrae (at PSIS level) to activate the pain-gating mechanism via cutaneous-visceral reflexes.

Frequency/Duration:

Each participant will receive a single session at their most painful day from this intervention

Myofascial Release Therapy (MRT) Group

Participants in this arm will receive a single session of myofascial release technique (MRT) which is a type of massage that will target anterolateral abdominal wall, including Camper and Scarpa fascia, as well as the deeper layers, including transversals fascia and the thoracolumbar fascia to release the fascial restrictions.

Group Type: EXPERIMENTAL

Myofascial Release Therapy (MRT) Group

Intervention Type: OTHER

Myofascial Release Therapy (MRT) involves hands-on palpation to detect fascial restrictions, followed by 60-90 seconds of sustained pressure to release tension. In the supine position, the target areas include the superficial fascia, transversalis fascia, and extraperitoneal fascia, while in the prone position, the focus shifts to the thoracolumbar fascia and the erector spinae complex. This technique aims to restore mobility and reduce restrictions within the fascial system.

Frequency: Each patient will recieve a single session at their most painful day from this intervention.

Interventions

Myofascial Release Therapy (MRT) Group

Myofascial Release Therapy (MRT) involves hands-on palpation to detect fascial restrictions, followed by 60-90 seconds of sustained pressure to release tension. In the supine position, the target areas include the superficial fascia, transversalis fascia, and extraperitoneal fascia, while in the prone position, the focus shifts to the thoracolumbar fascia and the erector spinae complex. This technique aims to restore mobility and reduce restrictions within the fascial system.

Frequency: Each patient will recieve a single session at their most painful day from this intervention.

Intervention Type: OTHER

Kinesiotape (KT) Group

Kinesio Taping (KT) Intervention

Description:

Participants will receive a standardized 3-tape sensory modulation technique using Kinesiotape, applied to the abdomen and sacrum to target fascial tension and visceral pain in primary dysmenorrhea.

Procedure:

Abdominal Application (Two Tapes, 0% Stretch):

Horizontal Tape: Placed between the iliac crests (lower abdomen) to reduce fascial tension.

Vertical Tape: Applied from the navel to the pubic symphysis to modulate visceral pain signaling.

Sacral Application (One Tape, 15-25% Stretch):

Horizontal Tape: Anchored across the S2-S4 vertebrae (at PSIS level) to activate the pain-gating mechanism via cutaneous-visceral reflexes.

Frequency/Duration:

Each participant will receive a single session at their most painful day from this intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Salma Abdelzaher

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gizem Ergezen Şahin, PhD

Role: STUDY_CHAIR

Medipol University

Locations

İstanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Salma Abdelzaher

Role: CONTACT

salma.abdelzaher@std.medipol.edu.tr

+90 5411086862

Facility Contacts

Salma Abdelzaher

Role: primary

salma.abdelzaher@std.medipol.edu.tr

+90 541 108 68 62

Other Identifiers

E-10840098-202.3.02-582

Identifier Type: -

Identifier Source: org_study_id