Effect of Manual Therapy on Migraine in Postmenopausal Women

NCT07127107 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005876
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of manual therapy on migraine in postmenopausal women.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• 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

  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 \[highest\]).

  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.

  8 weeks

Secondary Outcomes (1)

• Migraine-Specific Quality of Life Questionnaire (MSQv2.1)

  8 weeks

Study Arms (2)

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

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.

Drug: Non-steroidal anti-inflammatory drugs (NSAIDs); Other: Manual therapy techniques

Interventions

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 group and non-steroidal anti-inflammatory drugs (NSAIDs) group; Non-steroidal anti-inflammatory drugs (NSAIDs) group

Manual therapy techniques 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.

Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Mohamed Mohamed Yassen

Cairo, Egypt

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Hala Mahmoud, Professor

  Cairo University

  STUDY DIRECTOR

• Amel Youssef, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Marwa Yassen, PHD

CONTACT

01150897965; marwa2mb@gmail.com

Doaa A Osman, professor

CONTACT

01115792245; Doaa.osman@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 10, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

EG (1)