NCT07213336

Brief Summary

Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. In this controlled study, the effects of trigger point massage and stretching exercises applied to patients diagnosed with primary dysmenorrhea on pain severity (Visual Analog Scale), menstrual symptoms (Menstruation Symptom Scale) and quality of life (SF-36) were investigated. Forty-five women who were followed up with the diagnosis of Primary Dysmenorrhea in the Gynecology and Obstetrics Clinic of a local Hospital. Participants were randomly assigned to exercise, exercise+trigger point, and control groups using a computer-generated randomization list. The "Visual Analog Scale" was used to evaluate the severity of menstrual pain, "Menstruation Symptom Scale" was used to evaluate the severity of menstrual symptoms, and "SF-36" was used to evaluate the quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 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

December 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

September 17, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

Stretching exercisesmenstrual painprimary dysmenorrheatrigger point massage

Outcome Measures

Primary Outcomes (4)

  • SF-36

    SF-36: This questionnaire has 8 subscales, totaling 36 questions: 10 items on "physical function," 7 items on "role limitations due to physical (4 items) and emotional problems (3 items), 2 items on "pain," 4 items on "vitality," 2 items on "social function," 5 items on "mental health," and 5 items on "general health.

    The 1st and 3rd Most Painful Days of the Menstrual Cycle

  • Visual Analog Scale

    Visual Analog Scale: The visual analog scale (VAS) is the most commonly used tool for assessing pain intensity. It is easy to use, provides reproducible results, and can be applied to a variety of practice settings.

    The 1st and 3rd Most Painful Days of the Menstrual Cycle

  • Personal Information Form

    Personal Information Form: This form includes personal information.

    The 1st and 3rd Most Painful Days of the Menstrual Cycle

  • menstrual symptom scale

    It consists of a 5-point Likert-type scale with a total of 24 items. Individuals are asked to rate their menstruation-related symptoms between 1 (never) and 5 (always). The MBI score is calculated by averaging the total scores of the scale items. A higher mean score indicates an increased severity of menstrual symptoms.

    The 1st and 3rd Most Painful Days of the Menstrual Cycle

Study Arms (3)

1. group

NO INTERVENTION

Control group

2.group

EXPERIMENTAL

Stretching exercise group

Other: Exercise, massage

3.group

EXPERIMENTAL

trigger point massage and stretching exercise group

Other: Exercise, massage

Interventions

trigger point massage and stretching exercise

2.group3.group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being a woman between the ages of 18 and 30
  • Having a diagnosis of primary dysmenorrhea
  • Not having given birth
  • Having a regular menstrual cycle (28 ± 7 days)

You may not qualify if:

  • Having been diagnosed with rheumatic, gastrointestinal, psychiatric, neurological diseases, or other chronic pain syndromes
  • Being on any anti-inflammatory, analgesic, or estrogen/progestin pill (OCP) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

ExerciseMassage

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • melek g yavuzer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist physiotherapist

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 8, 2025

Study Start

December 1, 2022

Primary Completion

February 1, 2023

Study Completion

May 1, 2023

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

I do not want it to be shared without being published in any journal.

Locations