Primary DysmenorrheaNCT07307222
Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea
A study testing Standard physical therapy program and Transcutaneous Tibial Nerve Stimulation (TTNS) in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of Transcutaneous Tibial Nerve Stimulation (TTNS) on primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Standard physical therapy program and Transcutaneous Tibial Nerve Stimulation (TTNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with a regular menstrual cycle, experiencing primary dysmenorrhea, confirmed by history and clinical diagnosis.
- Females aged between 18 and 35 years.
- Their BMI ranging from 20 to 29.9 kg/m².
Who cannot join
- Females engaging in regular physical exercises prior to the study course.
- A history of abdominal or pelvic surgery.
- Pelvic pathologies or diseases (e.g., polycystic ovary syndrome, endometriosis, adenomyomas, or uterine fibroids).
- Malignant or benign neoplasms in the uterus.
- Chronic diseases, including diabetes and/or rheumatoid arthritis.
- Presence of metal implants or pacemakers.
- Any contraindications to the use of electrical stimulation (e.g., open wounds, some skin conditions…. etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mahitab Mohamed Yosri Ibrahim, PhD contact
Egypt1 site
Damas Central Hospital
Al Mansurah
Aya Atef Mahmoud Sonbol, B.Sc, +20 109 155 0191, aya.soonbol@gmail.com
About this study
This study will be conducted to evaluate the effect of Transcutaneous Tibial Nerve Stimulation (TTNS) on primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea is a common, disregarded, underdiagnosed, and inadequately treated complaint of both young and adult females. It negatively impacts the quality of life of young females, forming the main reason behind their absenteeism from school or work, and causing limitation of daily activities and psychological stress.
The Transcutaneous Tibial Nerve Stimulation (TTNS) is a rather new method acclaimed to be viable for chronic pelvic pain management. As it uses surface electrodes, it can be self-administrated by patients. Research is lacking regarding the effect of TTNS on primary dysmenorrhea. Thus, this study will be designed to examine the effect of TTNS on menstrual pain and distress as well as quality of life in females with primary dysmenorrhea. Study results will have valuable benefits in the physical therapy field, scientific research and medical and health organizations.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Standard physical therapy program, Transcutaneous Tibial Nerve Stimulation (TTNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapy programOther
The standard physical therapy program will include the application of a hot pack or heating pad to the lower abdomen or lower back for 15-20 minutes per session, three times per week for a duration of 12 weeks. The temperature of the hot pack will be maintained between 40°C and 45°C (104°F-113°F). In addition, participants will perform six stretching exercises for 30-45 minutes per session, also three times per week for 12 weeks.
Transcutaneous Tibial Nerve Stimulation (TTNS)Other
The TTNS intervention will be applied once a week for 30-minute sessions over 12 weeks. The EV-906 electrostimulation device will be used for the treatment. A symmetrical biphasic current will be applied in continuous mode at 20 Hz and 200 μs. The patient will be in a supine position with knees flexed and abducted at a 90-degree angle. Stimulation will be applied to both legs using two adhesive electrodes placed cranially to the internal malleolus of each leg, with additional electrodes placed at the ipsilateral calcaneus. The stimulation intensity will be regulated between 1 and 30 mA.
| Study group | Role | What they receive |
|---|---|---|
| Standard physical therapy program | Active comparator | It will include 18 females with primary dysmenorrhea who will receive standard physical therapy program for 3 months. Hot pack or heating pad will be applied to the lower abdomen or lower back area for 15-20 minutes per session, with 3 sessions per week over a period of 12 weeks. Six stretching exercises will be applied.The females will be instructed to perform the exercise 3 days/week. Receives: Other: Standard physical therapy program |
| Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS) | Experimental | It will include 18 females with primary dysmenorrhea who will receive TTNS 30 minutes once a week for 12 weeks, in addition to the same physical therapy program. Receives: Other: Standard physical therapy program; Other: Transcutaneous Tibial Nerve Stimulation (TTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Menstrual pain intensity
Using the Visual Analog Scale (VAS), each female will be asked to rate her menstrual pain intensity by placing a mark along the line that corresponds to their perceived pain level now. The distance from the "no pain" end to the female's mark will be then measured in centimeters to quantify the pain intensity. A higher value indicates greater pain intensity.
Measured: 3 months
Assessment of Menstrual Distress
Using the Menstrual Distress Questionnaire (MEDI-Q), each participant will report physical, emotional, and social symptoms experienced during menstruation over the past 12 months and rate their impact on daily functioning and quality of life. The questionnaire uses a Likert scale to evaluate symptoms from the most recent cycle, and a total score is obtained by summing responses. Higher scores indicate greater menstrual distress and more substantial psychological and physical effects.
Measured: 3 months
Assessment of Menstrual symptoms
Using the WaLIDD score, each female will be asked to answer questions by putting a score regarding five key factors related to primary dysmenorrhea: Working ability, Location of pain, Intensity of pain, Days of pain, and the presence of Dysmenorrhea. Each factor is scored based on the female's experience during their menstrual cycle. The scores from all factors are combined to produce a total score, with a higher score indicating greater severity and impact of dysmenorrhea.
Measured: 3 months
Secondary outcomes (1)
Assessment of Quality of Life
The World Health Organization Quality of Life (WHOQOL-26) questionnaire will be used to assess each participant's perceived quality of life, health, and daily functioning. Participants answer all items and are advised to select the response that feels most appropriate, often their first instinct. Scores for the four domains-physical, psychological, social, and environmental-are averaged to produce an overall score. Higher scores indicate better quality of life, while lower scores reflect greater impairment. This tool helps evaluate how conditions such as dysmenorrhea affect overall well-being.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start21 Dec 2025 (estimated)
- Primary completion21 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Atef Mahmoud Sonbol, Cairo University
- Investigators
- Afaf Mohamed Botla, PhD, Study chair, Assistant Professor, Cairo UniversityHossam Eldeen Hussein Kamel, PhD, Study director, Professor, Al-Azhar universityMahitab Mohamed Yosri Ibrahim, PhD, Study director, Lecturer, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307222
- Sponsor's protocol ID
- P.T.REC/012/005880
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07307222
- Acronym / sponsor ID
- P.T.REC/012/005880
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Dec 2025 (estimated)
- Primary completion
- 21 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
This study will be conducted to evaluate the effect of Transcutaneous Tibial Nerve Stimulation (TTNS) on primary dysmenorrhea.
Detailed description
Primary dysmenorrhea is a common, disregarded, underdiagnosed, and inadequately treated complaint of both young and adult females. It negatively impacts the quality of life of young females, forming the main reason behind their absenteeism from school or work, and causing limitation of daily activities and psychological stress.
The Transcutaneous Tibial Nerve Stimulation (TTNS) is a rather new method acclaimed to be viable for chronic pelvic pain management. As it uses surface electrodes, it can be self-administrated by patients. Research is lacking regarding the effect of TTNS on primary dysmenorrhea. Thus, this study will be designed to examine the effect of TTNS on menstrual pain and distress as well as quality of life in females with primary dysmenorrhea. Study results will have valuable benefits in the physical therapy field, scientific research and medical and health organizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physical therapy program | Active comparator | Other: Standard physical therapy programIt will include 18 females with primary dysmenorrhea who will receive standard physical therapy program for 3 months. Hot pack or heating pad will be applied to the lower abdomen or lower back area for 15-20 minutes per session, with 3 sessions per week over a period of 12 weeks. Six stretching exercises will be applied.The females will be instructed to perform the exercise 3 days/week. |
| Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS) | Experimental | Other: Standard physical therapy program, Other: Transcutaneous Tibial Nerve Stimulation (TTNS)It will include 18 females with primary dysmenorrhea who will receive TTNS 30 minutes once a week for 12 weeks, in addition to the same physical therapy program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females with a regular menstrual cycle, experiencing primary dysmenorrhea, confirmed by history and clinical diagnosis.
- Females aged between 18 and 35 years.
- Their BMI ranging from 20 to 29.9 kg/m².
Key exclusion criteria (7 listed)
- Females engaging in regular physical exercises prior to the study course.
- A history of abdominal or pelvic surgery.
- Pelvic pathologies or diseases (e.g., polycystic ovary syndrome, endometriosis, adenomyomas, or uterine fibroids).
- Malignant or benign neoplasms in the uterus.
- Chronic diseases, including diabetes and/or rheumatoid arthritis.
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 |
|---|---|---|
| Standard physical therapy programThe standard physical therapy program will include the application of a hot pack or heating pad to the lower abdomen or lower back for 15-20 minutes per session, three times per week for a duration of 12 weeks. The temperature of the hot pack will be maintained between 40°C and 45°C (104°F-113°F). In addition, participants will perform six stretching exercises for 30-45 minutes per session, also three times per week for 12 weeks. | Other | Standard physical therapy program, Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS) |
| Transcutaneous Tibial Nerve Stimulation (TTNS)The TTNS intervention will be applied once a week for 30-minute sessions over 12 weeks. The EV-906 electrostimulation device will be used for the treatment. A symmetrical biphasic current will be applied in continuous mode at 20 Hz and 200 μs. The patient will be in a supine position with knees flexed and abducted at a 90-degree angle. Stimulation will be applied to both legs using two adhesive electrodes placed cranially to the internal malleolus of each leg, with additional electrodes placed at the ipsilateral calcaneus. The stimulation intensity will be regulated between 1 and 30 mA. | Other | Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS) |
Primary outcome
Assessment of Menstrual pain intensity
Time frame: 3 months
Using the Visual Analog Scale (VAS), each female will be asked to rate her menstrual pain intensity by placing a mark along the line that corresponds to their perceived pain level now. The distance from the "no pain" end to the female's mark will be then measured in centimeters to quantify the pain intensity. A higher value indicates greater pain intensity.
Assessment of Menstrual Distress
Time frame: 3 months
Using the Menstrual Distress Questionnaire (MEDI-Q), each participant will report physical, emotional, and social symptoms experienced during menstruation over the past 12 months and rate their impact on daily functioning and quality of life. The questionnaire uses a Likert scale to evaluate symptoms from the most recent cycle, and a total score is obtained by summing responses. Higher scores indicate greater menstrual distress and more substantial psychological and physical effects.
Assessment of Menstrual symptoms
Time frame: 3 months
Using the WaLIDD score, each female will be asked to answer questions by putting a score regarding five key factors related to primary dysmenorrhea: Working ability, Location of pain, Intensity of pain, Days of pain, and the presence of Dysmenorrhea. Each factor is scored based on the female's experience during their menstrual cycle. The scores from all factors are combined to produce a total score, with a higher score indicating greater severity and impact of dysmenorrhea.
1 secondary outcome
Assessment of Quality of Life
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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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.
Mahitab Mohamed Yosri Ibrahim, PhD contact
Afaf Mohamed Botla, PhD study chair
Assistant Professor, Cairo University
Hossam Eldeen Hussein Kamel, PhD study director
Professor, Al-Azhar university
Mahitab Mohamed Yosri Ibrahim, PhD study director
Lecturer, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical therapy program and Transcutaneous Tibial Nerve Stimulation (TTNS) in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Dec 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Atef Mahmoud Sonbol, B.Sc (+20 109 155 0191, aya.soonbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Menstrual pain intensity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.