Effect of Manual Therapy on Migraine in Postmenopausal Women

NCT ID: NCT07127107

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-03-10

Brief Summary

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

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-steroidal anti-inflammatory drugs (NSAIDs) group

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

Group Type: ACTIVE_COMPARATOR

Non-steroidal anti-inflammatory drugs (NSAIDs)

Intervention Type: 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 group and non-steroidal anti-inflammatory drugs (NSAIDs) group

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.

Group Type: EXPERIMENTAL

Non-steroidal anti-inflammatory drugs (NSAIDs)

Intervention Type: 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 techniques

Intervention Type: OTHER

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:

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.

Interventions

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

Intervention Type: DRUG

Manual therapy techniques

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:

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Artificial or premature menopause
• Recent head trauma.
• Cerebral aneurysm or rupture.
• Tumors.
• Acute intracerebral bleeding.
• Hormonal replacement therapy.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Mohamed Yassen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Mahmoud, Professor

Role: STUDY_DIRECTOR

Cairo University

Amel Youssef, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Marwa Mohamed Mohamed Yassen

Cairo, , Egypt

Countries

Egypt

Central Contacts

Marwa Yassen, PHD

Role: CONTACT

marwa2mb@gmail.com

01150897965

Doaa A Osman, professor

Role: CONTACT

Doaa.osman@cu.edu.eg

01115792245

Other Identifiers

P.T.REC/012/005876

Identifier Type: -

Identifier Source: org_study_id