- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925087
Comparison of Acute Effects of Myofascial Release and Kinesio Taping® in Dysmenorrhea (Dysmenorrhea)
April 6, 2025 updated by: Mehmet Miçooğulları, Cyprus International University
Myofascial Release Versus Kinesio Taping: Which is More Effective for Dysmenorrhea Relief
Dysmenorrhea is a physiological condition and one of the most common issues experienced during menstruation.
This study aims to compare the acute effects of Myofascial Release Technique (MRT) and Kinesio Taping® (KT) on pain severity, fatigue, and menstrual symptom severity in individuals with primary dysmenorrhea (PD).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A total of 45 individuals diagnosed with PD will be randomly assigned to one of three groups: MRT, KT, or control.
Pain severity and fatigue will be measured using the Visual Analog Scale (VAS), while menstrual symptom severity will be assessed with the Menstrual Symptom Scale, both prior to and following the interventions.
The MRT group will be received MRT for three consecutive days starting from the onset of menstruation, whereas the KT group will be applied KT application for a duration of 72 hours.
The control group did not receive any form of intervention.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haspolat
-
Mersin, Haspolat, Turkey, 99040
- Cyprus International University
-
-
Lefkosa
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Mersin, Lefkosa, Turkey, 99040
- Cyprus International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Daignosed with primary dysmenorrhea
- Regular menstruation in the past six months
- Experience menstrual pain ranging between 40-100 mm on the Visual Analog Scale
Exclusion Criteria:
- Diagnosis of secondary dysmenorrhea
- A menstrual cycle length of less than 21 days or more than 35 days
- A history of childbirth or pregnancy
- Use of pharmacological treatments for menstrual pain
- A history of pelvic pathology or pelvic surgery
- The presence of neurological or systemic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Myofascial Release Technique Group
During the application of Myofascial Release Technique (MRT), the fingers or hand will be first placed on the treatment area.
Pressure will be applied to the soft tissue until the restricted layer was felt, and then the fascia was moved along the surface of the underlying layers while maintaining contact with the deeper layers.
Tension will be applied for approximately 60-90 seconds, and if a release will not felt, the duration will extended until the release occurred.
MRT will be performed with dry hands, without the use of any intermediary substances, and will be applied in both supine and prone positions.
In the treatment program, anterolateral release techniques (targeting fascia superficialis, fascia transversalis, and fascia extraperitonealis) will be applied in the supine position, while posterior release techniques (targeting fascia thoracolumbalis and erector spinae) will be applied in the prone position.
|
During the application of Myofascial Release Technique (MRT), the fingers or hand will be first placed on the treatment area.
Pressure will be applied to the soft tissue until the restricted layer was felt, and then the fascia was moved along the surface of the underlying layers while maintaining contact with the deeper layers.
Tension will be applied for approximately 60-90 seconds, and if a release will not felt, the duration will extended until the release occurred.
MRT will be performed with dry hands, without the use of any intermediary substances, and will be applied in both supine and prone positions.
In the treatment program, anterolateral release techniques (targeting fascia superficialis, fascia transversalis, and fascia extraperitonealis) will be applied in the supine position, while posterior release techniques (targeting fascia thoracolumbalis and erector spinae) will be applied in the prone position.
|
|
Active Comparator: Kinesio Taping Group
Two different techniques will be used in the Kinesio Taping application.
First, four I-shaped Kinesio tapes (Kinesio Tex® Gold), each 5 cm wide and 0.5 mm thick, will be applied in a star-shaped pattern using the "space correction technique" with 25-50% tension at the S2-S4 level (sacral region) while the participant will in a seated position.
Additionally, to direct the uterus into retroversion during menstruation, a 15 cm long I-shaped tape will be applied to the suprapubic region using the "ligament correction technique" with 100% tension.
|
Two different techniques will be used in the Kinesio Taping application.
First, four I-shaped Kinesio tapes (Kinesio Tex® Gold), each 5 cm wide and 0.5 mm thick, will be applied in a star-shaped pattern using the "space correction technique" with 25-50% tension at the S2-S4 level (sacral region) while the participant will in a seated position.
Additionally, to direct the uterus into retroversion during menstruation, a 15 cm long I-shaped tape will be applied to the suprapubic region using the "ligament correction technique" with 100% tension.
|
|
No Intervention: Control Group
No intervention will be applied to the control group.
After the study will be completed, participants in the control group will be offered their preferred treatment option.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Severity
Time Frame: 3 months
|
A 100 mm Visual Analog Scale (VAS), represented as a straight line with one end marked as 0 (no pain) and the other end as 10 (unbearable pain), will be used to measure pain severity.
Participants will be asked to mark the point on the line that corresponded to the level of pain they will be experiencing during the evaluation.
The marked point will be then measured using a ruler, and the numerical value of the pain severity will be recorded.
Higher results indicate worse pain intensity.
|
3 months
|
|
Fatigue
Time Frame: 3 months
|
A 100 mm Visual Analog Scale (VAS), with one end marked as 0 (no fatigue) and the other end as 10 (unbearable fatigue), will be used to evaluate the severity of fatigue experienced on the most intense day of menstruation.
Participants will be asked to mark the point on the VAS that corresponded to the level of fatigue they will be felt.
The marked point will then measured using a ruler, and the numerical value will be recorded.
Higher results indicate worse pain intensity.
|
3 months
|
|
Menstrual Symptoms
Time Frame: 3 months
|
The "Menstrual Symptom Scale," developed by Chesney and Tatso, will be used to evaluate the severity of menstrual symptoms.
This scale consists of 22 items, each with five response options, and includes three subdimensions.
The first 13 items belong to the "Negative Effects/Somatic Complaints" subdimension, items 14 to 19 fall under the "Menstrual Pain Symptoms" subdimension, and the last three items are part of the "Coping Methods" subdimension.
The responses will be rated on a Likert-type scale ranging from 1 (never) to 5 (always).
A higher total score indicates greater severity of menstrual symptoms.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mehmet Miçooğulları, PhD, Cyprus International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ma YX, Ma LX, Liu XL, Ma YX, Lv K, Wang D, Liu JP, Xing JM, Cao HJ, Gao SZ, Zhu J. A comparative study on the immediate effects of electroacupuncture at Sanyinjiao (SP6), Xuanzhong (GB39) and a non-meridian point, on menstrual pain and uterine arterial blood flow, in primary dysmenorrhea patients. Pain Med. 2010 Oct;11(10):1564-75. doi: 10.1111/j.1526-4637.2010.00949.x. Epub 2010 Sep 7.
- Kaur, A., Ray, G., & Mitra, M. (2017). Comparing the effectiveness of connective tissue mobilisation and kinesio-taping on females with primary dysmenorrhea. Indian Journal of Physiotherapy & Occupational Therapy, 11, 70-5.
- Harel Z. Dysmenorrhea in adolescents and young adults: etiology and management. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):363-71. doi: 10.1016/j.jpag.2006.09.001.
- Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
- Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011 Oct;15(4):431-5. doi: 10.1016/j.jbmt.2011.01.021. Epub 2011 Feb 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2022
Primary Completion (Actual)
November 14, 2022
Study Completion (Actual)
February 20, 2025
Study Registration Dates
First Submitted
April 6, 2025
First Submitted That Met QC Criteria
April 6, 2025
First Posted (Actual)
April 13, 2025
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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