Clinical trial NCT05557500: Assessment of Psychological Symptoms Among Fibromyalgia Patients
Official title: Assessment of Psychological Symptoms and Quality if Life Among Fibromyalgia Patients and Its Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Symptoms in Fibromyalgia Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate prevelance of psychiatric disorders among fibromyalgia patients
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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