Assessment of Psychological Symptoms Among Fibromyalgia Patients

Study Overview
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Brief Summary
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Fibromyalgia is a syndrome characterized by chronic widespread pain at multiple tender points, joint stiffness, and systemic symptoms (e.g., mood disorders, fatigue, cognitive dysfunction, and insomnia) [14] without a well-defined underlying organic disease. Nevertheless, it can be associated with specific diseases such as rheumatic pathologies, psychiatric or neurological disorders, infections, and diabetes. The prevalence of fibromyalgia has been estimated to be around 1%-2% (3.4% for women and 0.5% for men) [5, 6].

Detailed Description
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The etiology and pathogenesis of fibromyalgia are still not fully understood. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. diagnosis is principally based on the two major diagnostic criteria defined by the ACR in 1990 [7]: (1) a history of widespread musculoskeletal pain present for at least three months, and (2) tenderness in at least 11 of 18 defined tender points Psychiatric problems seem to contribute considerably to the development of fibromyalgia. The prevalence of psychiatric conditions among patients affected by fibromyalgia is higher than among subjects complaining of other rheumatic diseases . The most common disorders associated are anxiety, somatization, dysthymia, panic disorders, posttraumatic stress, and overall depression [8]. Depression is more frequently associated with fibromyalgia than with other musculoskeletal diseases [9] Depression worsens fibromyalgic symptoms and vice versa, and antidepressants represent a cornerstone of fibromyalgia therapy [1011]. Over the last decade, it has been repeatedly shown that noninvasive repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) induces analgesic effects both in experimental pain [1216] , probably by activating pain modulation systems. Another way studied to relieve fibromyalgia pain is sphenopalatine ganglion block In our study we will evaluate the effect of repetitive transcranial magnetic stimulation and sphenopalatine ganglion block on fibromyalgia pain and psychiatric symptoms. rtms will be applied on primary motor area (M1) for 20 sessions (5 daily per week for 4 weeks)with 20 HZ and 3000pul with evaluation of pain and psychological symptoms befor intervention and after 10 sesions and after 1 month of last session compared to sphenopalatine ganglion block effect .

Official Title
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Assessment of Psychological Symptoms and Quality if Life Among Fibromyalgia Patients and Its Risk Factors

Conditions
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Psychological Symptoms in Fibromyalgia Patients

Intervention / Treatment
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* Device: Repitetive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Women aged from 18 to 60 years old Diagnosed as fibromyalgia with resistence to pharmacological treatment Exclusion Criteria: Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibromyalgia patients with use of rtms sessions for treatment<br>Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions | Device: Repitetive transcranial magnetic stimulation<br>* Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions<br>|
| Experimental: Fibromyalgia pt with use of sphenopalatine ganglion block as treatment<br>Pain killing intervention for pain control of myofacial pain in fibromyalgia patients | Device: Repitetive transcranial magnetic stimulation<br>* Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate prevelance of psychiatric disorders among fibromyalgia patients | Identify possible risk factors that lead to psychiatric illness in fibromyalgia patients Evaluate effect of non pharmacological treatment in form of sphenopalatine ganglion block and transcranial mag netic stimulation on psychiatric symptoms in fibromyalgia patients | 3 years |