NCT06925087

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 6, 2025

Last Update Submit

April 6, 2025

Conditions

Keywords

Kinesio TapingMenstruationPrimary dysmenorrheaMyofascial release techniquePhysiotherapy

Outcome Measures

Primary Outcomes (3)

  • Pain Severity

    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

    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

    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

Study Arms (3)

Myofascial Release Technique Group

ACTIVE COMPARATOR

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.

Other: Myofascial Release Technique

Kinesio Taping Group

ACTIVE COMPARATOR

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.

Other: Kinesio Taping Technique

Control Group

NO INTERVENTION

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.

Interventions

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.

Myofascial Release Technique 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.

Kinesio Taping Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Daignosed with primary dysmenorrhea
  • Regular menstruation in the past six months
  • Experience menstrual pain ranging between 40-100 mm on the Visual Analog Scale

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cyprus International University

Mersin, Haspolat, 99040, Turkey (Türkiye)

Location

Cyprus International University

Mersin, Lefkosa, 99040, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Mehmet Miçooğulları, PhD

    Cyprus International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All treatments will be performed by the same physiotherapist, and assessments will be conducted twice: pre-treatment and post-treatment. Post-treatment assessments will be performed after the third MRT session for Group 1 and 72 hours after the KT application for Group 2. This will be a single-blind study, with all assessments carried out by a physiotherapist blinded to the treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 13, 2025

Study Start

February 6, 2022

Primary Completion

November 14, 2022

Study Completion

February 20, 2025

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations