Assessment of Psychological Symptoms Among Fibromyalgia Patients

NCT ID: NCT05557500

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-25
• Study Completion Date: 2024-03-31

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 .

Conditions

Psychological Symptoms in Fibromyalgia Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fibromyalgia patients with use of rtms sessions for treatment

Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions

Group Type: EXPERIMENTAL

Repitetive transcranial magnetic stimulation

Intervention Type: DEVICE

Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions

Fibromyalgia pt with use of sphenopalatine ganglion block as treatment

Pain killing intervention for pain control of myofacial pain in fibromyalgia patients

Group Type: EXPERIMENTAL

Repitetive transcranial magnetic stimulation

Intervention Type: DEVICE

Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions

Interventions

Repitetive transcranial magnetic stimulation

Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

CA Adeeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hossameldin Khalifa

Role: CONTACT

hossamkhalifa71@aun.edu.eg

01006266237

Ahmed Abdelbaki

Role: CONTACT

ahmedbaki2020@yahoo.com

01096477803

References

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Reference Type: BACKGROUND

PMID: 18576297 (View on PubMed)

Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

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Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthritis Rheum. 2003 Oct;48(10):2916-22. doi: 10.1002/art.11272.

Reference Type: BACKGROUND

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[1990 classification criteria of fibromyalgia from the American College of Rheumatology. Report of the Multicenter Criteria Committee]. Union Med Can. 1990 Sep-Oct;119(5):272. No abstract available. French.

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Other Identifiers

APF

Identifier Type: -

Identifier Source: org_study_id