Primary DysmenorrheaNCT07314021
Primary Dysmenorrhea and Mobilization.
A study testing FEMOB, MOPEXE and Conventional Treatment group in people with Primary Dysmenorrhea, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- FEMOB, MOPEXE and Conventional Treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- FEMOB, MOPEXE, Conventional Treatment group
- Keywords
- mobilization, primary dysmenorrhea, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEMOBOther
FEMOB is a structured multimodal mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.
MOPEXEOther
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.
Conventional Treatment groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FEMOB | Active comparator | 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. Receives: Other: FEMOB |
| MOPEXE | Active comparator | 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. Receives: Other: MOPEXE |
| Conventional treatment group | Other | 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. Receives: Other: Conventional Treatment group |
| CONTROL | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form McGill Pain Questionnaire Total Pain Score
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.
Measured: 12 weeks
Secondary outcomes (4)
Menstrual Attitude Questionnaire
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;
- Menstruation as a debilitating event
- Menstruation as a bothersome event
- Menstruation as a natural event
- Ancipitation and prediction of the onset of menstruation
- Denial of any effect of menstruation
Measured: 12 weeks
Functional and Emotional Dysmenorrhea Scale
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.
Measured: 12 weeks
Menstrual Symptom Questionnaire
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.
Measured: 12 weeks
The Menstrual Distress Questionnaire
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start5 Dec 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP BETÜL BİLGİ, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314021
- Sponsor's protocol ID
- E-10840098-202.3.02-4605
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32379680
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Structured FEMOB Mobilization Technique and the MOPEXE Exercise Model in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07314021
- Acronym / sponsor ID
- E-10840098-202.3.02-4605
- Conditions
- Primary Dysmenorrhea
- Keywords
- mobilization, primary dysmenorrhea, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FEMOB | Active comparator | Other: FEMOBStructured multimodal mobilization (FEMOB) is a manual therapy-based mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping. |
| MOPEXE | Active comparator | Other: MOPEXEParticipants 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. |
| Conventional treatment group | Other | Other: Conventional Treatment groupThe 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. |
| CONTROL | No intervention | –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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEMOBFEMOB is a structured multimodal mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping. | Other | FEMOB |
| MOPEXEMOPEXE 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 | MOPEXE |
| Conventional Treatment groupThe 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. | Other | Conventional treatment group |
Primary outcome
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.
4 secondary outcomes
Menstrual Attitude Questionnaire
Time frame: 12 weeks
Functional and Emotional Dysmenorrhea Scale
Time frame: 12 weeks
Menstrual Symptom Questionnaire
Time frame: 12 weeks
The Menstrual Distress Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 32379680Toprak 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEMOB, MOPEXE and Conventional Treatment group in people with Primary Dysmenorrhea, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form McGill Pain Questionnaire Total Pain Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.