Assessment of Psychological Symptoms Among Fibromyalgia Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05557500
Collaborator
(none)
40
2
17.2

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase
  • Device: Repitetive transcranial magnetic stimulation
N/A

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Psychological Symptoms and Quality if Life Among Fibromyalgia Patients and Its Risk Factors
Anticipated Study Start Date :
Sep 25, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fibromyalgia patients with use of rtms sessions for treatment

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

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

Experimental: Fibromyalgia pt with use of sphenopalatine ganglion block as treatment

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

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate prevelance of psychiatric disorders among fibromyalgia patients [3 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
CA Adeeb, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05557500
Other Study ID Numbers:
  • APF
First Posted:
Sep 28, 2022
Last Update Posted:
Sep 28, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2022