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Not yet recruiting NCT07127107

Effect of Manual Therapy on Migraine in Postmenopausal Women

No phase Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-steroidal anti-inflammatory drugs (NSAIDs), Manual therapy techniques.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: 50 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug 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
  • Other 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

Primary outcome measures

  • Pressure Pain Threshold (PPT) [Time frame: 8 weeks]
  • Migraine disability assessment Questionnaire : [Time frame: 8 weeks]
  • The blink reflexometer [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Migraine-Specific Quality of Life Questionnaire (MSQv2.1) [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Marwa Mohamed Mohamed Yassen — Cairo

Identifiers

NCT: NCT07127107 · P.T.REC/012/005876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗