MigraineNCT07127107
Effect of Manual Therapy on Migraine in Postmenopausal Women
A study testing Non-steroidal anti-inflammatory drugs (NSAIDs) and Manual therapy techniques in people with Migraine, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the effect of manual therapy on migraine in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Non-steroidal anti-inflammatory drugs (NSAIDs) and Manual therapy techniques
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2025to 10 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women are postmenopausal at least one year following last menstruation.
- They are suffering from migraine.
- Their ages will range from 50 to 60 years old.
- Their body mass index (BMI) will not exceed 30 Kg/m2.
- Women with regular or irregular attacks of migraine.
Who cannot join
- Artificial or premature menopause
- Recent head trauma.
- Cerebral aneurysm or rupture.
- Tumors.
- Acute intracerebral bleeding.
- Hormonal replacement therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of the study is to determine the effect of manual therapy on migraine in postmenopausal women.
Read the detailed description
Menopause is a period of great changes to women's bodies and minds. Alterations to body image and emotions, psychological adjustment to a new phase of life and worries about the higher prevalence of severe diseases and cognitive dysfunction all contribute towards negatively affecting the quality of life of menopausal patients. Symptoms that are typical of hormonal deprivation and aging are prevalent and distressful to many, often requiring individual counseling and specific therapies. Some of the symptoms are manageable and headache is certainly a modifiable parameter if given the appropriate treatment. About one third of the women had experienced worsening of their primary headaches after their last menstrual period, which contradicts the popular belief that "after menopause the headache gets better.
Migraine is a severe headache often felt as a throbbing pain - and usually occurring on one side of the head. It often comes with nausea or vomiting, and a heightened sensitivity to light or sound. The headache is such that it stops doing what is normally do and can last from four to 72 hours .
Soft tissue massage of the paraspinal muscles, jaw muscles will all help decrease the muscle spasm of tension headaches. Joint Manipulation: this can be done with manipulative techniques or gentle articulation techniques to encourage joint release and movement By manipulating the bones of skull and the dura mater that is a membrane just below the skull, craniosacral therapy also relieves arterial pressure to ease pain.
There is dearth of knowledge regarding the effect of manual therapy on migraine in postmenopausal women. This study, therefore, contributes valuable insights to a relatively unexplored area of
- Conditions
- Migraine
- Being tested
- Non-steroidal anti-inflammatory drugs (NSAIDs), Manual therapy techniques
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-steroidal anti-inflammatory drugs (NSAIDs)Drug
For mild and moderate migraines e.g Ibuprofen and aspirin.
- Aspirin: Peroral (PO) tablet with standard dosages of 325 mg, 500 mg, and 400 mg effervescent; treatment dosage of up to 1000 mg
- Ibuprofen: PO tablet with standard dosages of 200 mg, 400 mg, 600 mg, and 800 mg; treatment dosage of 200 to 800 mg
Manual therapy techniquesOther
Cranial manipulative osteopathy: Tension release of cranial sutures is applied while the patient in supine lying position, a pressure of 200g to3kg is applied with both thumbs for 30-40 sec or till release occurs. it includes:
- Coronal suture The head is directed to one side and the pressure is applied with both thumbs directed parallel to each otheralong the coronal suture.
- Sagital suture distraction The head is in the central position and the pressure is applied with both thumbs directed parallel to each other along the sagittal suture.
- Squamous suture distraction The head is directed to one side and the pressure is applied with both thumbs parallel along the squamous suture.
- Lamboidal suture distraction: The head is directed to one side and the thumbs directed parallel to each other along the lamboidal suture.
- Occipitomastoid suture distraction The head is directed to one side and both thumbs directed parallel to each other along occipitomastoid suture.
| Study group | Role | What they receive |
|---|---|---|
| Non-steroidal anti-inflammatory drugs (NSAIDs) group | Active comparator | The participants will receive non-steroidal anti-inflammatory drugs (NSAIDs) to relieve the pain and symptoms of a migraine attack and help prevent further migraine attacks Receives: Drug: Non-steroidal anti-inflammatory drugs (NSAIDs) |
| Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group | Experimental | The participants will receive the same medical treatment (non-steroidal anti-inflammatory drugs (NSAIDs)) plus manual therapy techniques for 3 times per week for 8 weeks. Receives: Drug: Non-steroidal anti-inflammatory drugs (NSAIDs); Other: Manual therapy techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT)
Pressure algometry (PA) is a method described to objectify pressure pain threshold PPT.
Application:
- Frontal muscle (2 cm above the surfacing of the supra orbital branch of the trigeminal nerve) Medium temporalis muscle (located 2 cm to the lateral rim of the eyebrow)
- Masseter muscle (origin: anterior rim of the surface portion of the muscle; insertion: lower most prominent region identified by manual palpation during maximal dental clenching, and belly: the mid-point between the origin and the insertion) ;
- Trapezius (insertion: the point immediately below the occipital bone, located in the sub-occipital region; upper fibers: mid-point between the spinous process of seventh cervical vertebrae (C 7) and the acromion);
- Sternocleidomastoid muscle (upper portion: fibers below the mastoid process)
- PPT levels were obtained in three consecutive series bilaterally
Measured: 8 weeks
Migraine disability assessment Questionnaire :
Migraine Disability Assessment (MIDAS) questionnaire was designed to be brief, self-administered, and easy to score. It assesses not only missed days of activity, but also days in which productivity is reduced by at least half.
The MIDAS score is derived as the sum of missed days and days when productivity was reduced by at least half for work outside the home and household work, as well as missed days of nonwork activities (family, social, and leisure) during a 3-month period. The score, therefore, has units of lost days. Physicians graded each patient for pain level (mild, moderate, or severe), level of disability (none, mild, moderate, or severe), and need for medical care (from 0 [lowest] to 100 [highest]).
Measured: 8 weeks
The blink reflexometer
It is an electrodiagnostic test that evokes the corneal reflex. It evaluates the integrity of the trigeminal and facial nerve. The supraorbital branch of the ophthalmic division of the trigeminal nerve constitutes the afferent arm, while the motor fibers of the facial nerve form the efferent arm of this reflex.Normally, as with the corneal reflex, the ipsilateral electrical stimulation of the trigeminal nerve will produce an eye blink bilaterally.
The subject is supine and asked to stay relaxed with their eyes open or gently closed. The active electrode (A) is placed over the inferior aspect of the orbicularis oculus while the reference electrode (R) is placed either over the bony prominence of the zygomatic arch or the nose. The ground electrode (G) can be placed over the forehead or under the chin. Using a prong stimulator, each supraorbital nerve is stimulated and the response from the orbicularis oculus is recorded bilaterally.
Measured: 8 weeks
Secondary outcomes (1)
Migraine-Specific Quality of Life Questionnaire (MSQv2.1)
The MSQv2.1 measures quality of life among migraine patients during the past 4 weeks. It has three scales:(1) Role Restrictive (RR, original named Role Function-Restrictive in MSQv1), which includes seven items that assess how patients' performance of normal activities is limited by migraine; (2) Role Preventive (RP, original named Role Function-Preventive), which consists of four items that assess how patients' performance of normal activities is interrupted by migraines; and (3) Emotion Function (EF), which consists of three items that assess the impact of migraine on the respondent's emotions (e.g., frustration or helplessness). The item responses range from one to six (1 = "None of the time;" 2 = "A little bit of time;" 3 = "Some of the time;" 4 = "A good bit of the time;" 5 = "Most of the time;" 6 = "All of the time"). All items are reverse-coded, and standardized to a 0-100 scale. Thus, higher scale scores indicate better migraine-related quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Mohamed Yassen, Cairo University
- Investigators
- Hala Mahmoud, Professor, Study director, Cairo UniversityAmel Youssef, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127107
- Sponsor's protocol ID
- P.T.REC/012/005876
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Therapy on Migraine in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07127107
- Acronym / sponsor ID
- P.T.REC/012/005876
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 17 Aug 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.
The purpose of the study is to determine the effect of manual therapy on migraine in postmenopausal women.
Detailed description
Menopause is a period of great changes to women's bodies and minds. Alterations to body image and emotions, psychological adjustment to a new phase of life and worries about the higher prevalence of severe diseases and cognitive dysfunction all contribute towards negatively affecting the quality of life of menopausal patients. Symptoms that are typical of hormonal deprivation and aging are prevalent and distressful to many, often requiring individual counseling and specific therapies. Some of the symptoms are manageable and headache is certainly a modifiable parameter if given the appropriate treatment. About one third of the women had experienced worsening of their primary headaches after their last menstrual period, which contradicts the popular belief that "after menopause the headache gets better.
Migraine is a severe headache often felt as a throbbing pain - and usually occurring on one side of the head. It often comes with nausea or vomiting, and a heightened sensitivity to light or sound. The headache is such that it stops doing what is normally do and can last from four to 72 hours .
Soft tissue massage of the paraspinal muscles, jaw muscles will all help decrease the muscle spasm of tension headaches. Joint Manipulation: this can be done with manipulative techniques or gentle articulation techniques to encourage joint release and movement By manipulating the bones of skull and the dura mater that is a membrane just below the skull, craniosacral therapy also relieves arterial pressure to ease pain.
There is dearth of knowledge regarding the effect of manual therapy on migraine in postmenopausal women. This study, therefore, contributes valuable insights to a relatively unexplored area of
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-steroidal anti-inflammatory drugs (NSAIDs) group | Active comparator | Drug: Non-steroidal anti-inflammatory drugs (NSAIDs)The participants will receive non-steroidal anti-inflammatory drugs (NSAIDs) to relieve the pain and symptoms of a migraine attack and help prevent further migraine attacks |
| Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group | Experimental | Drug: Non-steroidal anti-inflammatory drugs (NSAIDs), Other: Manual therapy techniquesThe participants will receive the same medical treatment (non-steroidal anti-inflammatory drugs (NSAIDs)) plus manual therapy techniques for 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All women are postmenopausal at least one year following last menstruation.
- They are suffering from migraine.
- Their ages will range from 50 to 60 years old.
- Their body mass index (BMI) will not exceed 30 Kg/m2.
- Women with regular or irregular attacks of migraine.
Key exclusion criteria (6 listed)
- Artificial or premature menopause
- Recent head trauma.
- Cerebral aneurysm or rupture.
- Tumors.
- Acute intracerebral bleeding.
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 |
|---|---|---|
| Non-steroidal anti-inflammatory drugs (NSAIDs)For mild and moderate migraines e.g Ibuprofen and aspirin. * Aspirin: Peroral (PO) tablet with standard dosages of 325 mg, 500 mg, and 400 mg effervescent; treatment dosage of up to 1000 mg * Ibuprofen: PO tablet with standard dosages of 200 mg, 400 mg, 600 mg, and 800 mg; treatment dosage of 200 to 800 mg | Drug | Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group, Non-steroidal anti-inflammatory drugs (NSAIDs) group |
| Manual therapy techniquesCranial manipulative osteopathy: Tension release of cranial sutures is applied while the patient in supine lying position, a pressure of 200g to3kg is applied with both thumbs for 30-40 sec or till release occurs. it includes: 1. Coronal suture The head is directed to one side and the pressure is applied with both thumbs directed parallel to each otheralong the coronal suture. 2. Sagital suture distraction The head is in the central position and the pressure is applied with both thumbs directed parallel to each other along the sagittal suture. 3. Squamous suture distraction The head is directed to one side and the pressure is applied with both thumbs parallel along the squamous suture. 4. Lamboidal suture distraction: The head is directed to one side and the thumbs directed parallel to each other along the lamboidal suture. 5. Occipitomastoid suture distraction The head is directed to one side and both thumbs directed parallel to each other along occipitomastoid suture. | Other | Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: 8 weeks
Pressure algometry (PA) is a method described to objectify pressure pain threshold PPT. Application: * Frontal muscle (2 cm above the surfacing of the supra orbital branch of the trigeminal nerve) Medium temporalis muscle (located 2 cm to the lateral rim of the eyebrow) * Masseter muscle (origin: anterior rim of the surface portion of the muscle; insertion: lower most prominent region identified by manual palpation during maximal dental clenching, and belly: the mid-point between the origin and the insertion) ; * Trapezius (insertion: the point immediately below the occipital bone, located in the sub-occipital region; upper fibers: mid-point between the spinous process of seventh cervical vertebrae (C 7) and the acromion); * Sternocleidomastoid muscle (upper portion: fibers below the mastoid process) * PPT levels were obtained in three consecutive series bilaterally
Migraine disability assessment Questionnaire :
Time frame: 8 weeks
Migraine Disability Assessment (MIDAS) questionnaire was designed to be brief, self-administered, and easy to score. It assesses not only missed days of activity, but also days in which productivity is reduced by at least half. The MIDAS score is derived as the sum of missed days and days when productivity was reduced by at least half for work outside the home and household work, as well as missed days of nonwork activities (family, social, and leisure) during a 3-month period. The score, therefore, has units of lost days. Physicians graded each patient for pain level (mild, moderate, or severe), level of disability (none, mild, moderate, or severe), and need for medical care (from 0 [lowest] to 100 [highest]).
The blink reflexometer
Time frame: 8 weeks
It is an electrodiagnostic test that evokes the corneal reflex. It evaluates the integrity of the trigeminal and facial nerve. The supraorbital branch of the ophthalmic division of the trigeminal nerve constitutes the afferent arm, while the motor fibers of the facial nerve form the efferent arm of this reflex.Normally, as with the corneal reflex, the ipsilateral electrical stimulation of the trigeminal nerve will produce an eye blink bilaterally. The subject is supine and asked to stay relaxed with their eyes open or gently closed. The active electrode (A) is placed over the inferior aspect of the orbicularis oculus while the reference electrode (R) is placed either over the bony prominence of the zygomatic arch or the nose. The ground electrode (G) can be placed over the forehead or under the chin. Using a prong stimulator, each supraorbital nerve is stimulated and the response from the orbicularis oculus is recorded bilaterally.
1 secondary outcome
Migraine-Specific Quality of Life Questionnaire (MSQv2.1)
Time frame: 8 weeks
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 17 Aug 2025.
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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.
Hala Mahmoud, Professor study director
Cairo University
Amel Youssef, Professor study chair
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 Non-steroidal anti-inflammatory drugs (NSAIDs) and Manual therapy techniques in people with Migraine, 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 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: opening soon, as of the sponsor's last update on 17 Aug 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 Marwa Yassen, PHD (01150897965, marwa2mb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: 8 weeks). 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 17 Aug 2025.