Primary Dysmenorrhea and Mobilization.

June 28, 2026 updated by: ZEYNEP BETÜL BİLGİ, Medipol University

Comparison of the Structured FEMOB Mobilization Technique and the MOPEXE Exercise Model in Women With Primary Dysmenorrhea

72 women diagnosed with primary dysmenorrhea were included in the study and divided into four groups. the first group received treatment with a mobilization approach, the second group received motor imagery-focused exercises and the third group, as a electrotherapy group and fourth received no treatment was applied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18-30 years
  • Clinically confirmed primary dysmenorrhea
  • Regular menstrual cycles during the previous six months
  • Menstrual pain intensity of ≥4 cm on the Visual Analog Scale (VAS)
  • Voluntary agreement to participate in the study

Exclusion Criteria:

  • Secondary dysmenorrhea or gynecological pathology such as endometriosis, uterine fibroids, or pelvic inflammatory disease
  • Pregnancy
  • Pelvic physiotherapy within the previous six months
  • Neurological, rheumatological, or serious systemic disease
  • Communication difficulties preventing participation or questionnaire completion
  • Regular use of oral contraceptives

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: CONTROL
Participants in the control group received no active treatment, exercise program, or physiotherapy intervention during the study period. They were instructed to continue their routine daily activities and not to initiate any new pharmacological or non-pharmacological treatment for dysmenorrhea symptoms during the study.
Active Comparator: FEMOB
Structured multimodal mobilization (FEMOB) is a manual therapy-based mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.
Other: FEMOB
FEMOB is a structured multimodal mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.
Active Comparator: MOPEXE
Participants in the MOPEXE arm receive a 60-minute Pilates-based motor imagery-focused pelvic floor exercise program twice weekly for 12 weeks. Each session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation. Outcomes are assessed at baseline and after completion of the 12-week intervention period.
Other: MOPEXE
MOPEXE is a Pilates-based motor imagery-focused pelvic floor exercise program. Each 60-minute session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation. Sessions are delivered twice weekly for 12 weeks.
Other: Conventional treatment group
The conventional treatment arm receives TENS and hot pack application. TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions. Hot pack application is applied to the lumbar and suprapubic regions for a total of 20 minutes.
Other: Conventional Treatment group
The conventional treatment arm receives TENS and hot pack application. TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions. Hot pack application is applied to the lumbar and suprapubic regions for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-Form McGill Pain Questionnaire Total Pain Score
Time Frame: 12 weeks
Pain intensity was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ total pain score, calculated as the sum of sensory and affective pain descriptor scores, was defined as the primary outcome. Higher scores indicate greater pain severity.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Menstrual Attitude Questionnaire
Time Frame: 12 weeks

The Turkish version of the Menstrual Attitude Scale (MBI) will be applied to determine the attitudes and behaviors of the participants during the menstrual period. Menstruation attitude scale includes 5 subtitles. These subheadings are;

  1. Menstruation as a debilitating event
  2. Menstruation as a bothersome event
  3. Menstruation as a natural event
  4. Ancipitation and prediction of the onset of menstruation
  5. Denial of any effect of menstruation
12 weeks
Functional and Emotional Dysmenorrhea Scale
Time Frame: 12 weeks
This is a 14-item, 5-point Likert-type scale used to measure dysmenorrhea functionally and emotionally. There are no reverse items in the scale. The scale was developed to provide functional and emotional measurement of dysmenorrhea. As the scores obtained from the scale increase, the extent to which patients are functionally and emotionally affected by dysmenorrhea also increases.
12 weeks
Menstrual Symptom Questionnaire
Time Frame: 12 weeks
The scale consists of 22 items that inquire about menstrual symptoms and is scored on a five-point Likert scale, from never (1) to always (5). The scale, which consists of three sub-dimensions, is evaluated in the sub-dimension of 'Negative effects/somatic complaints' with items 1-13, the sub-dimension of 'Menstrual pain symptoms' with items 14-19, and the sub-dimension of 'Coping methods' with items 20-22. An increase in the mean score indicates an increase in the severity of menstrual symptoms related to the relevant sub-dimension.
12 weeks
The Menstrual Distress Questionnaire
Time Frame: 12 weeks
This is a self-reported assessment tool designed to comprehensively evaluate the physical and emotional symptoms experienced by individuals during their menstrual period. The scale consists of 25 questions, each with 5 sub-items, covering common symptoms such as abdominal pain, headache, nausea, irritability, and mood swings. Each item is scored using a Likert-type rating system to determine the frequency or severity with which the participant experiences the relevant symptom. As the total score on the scale increases, the intensity of the symptoms experienced during menstruation and their negative impact on daily life also increase. In this context, high scores indicate increased symptom severity and decreased quality of life. The scale offers a holistic assessment by encompassing both the somatic and emotional dimensions of menstruation-related symptoms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-202.3.02-4605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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