Assessment of Psychological Symptoms Among Fibromyalgia Patients

September 25, 2022 updated by: CA Adeeb, Assiut University

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

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate prevelance of psychiatric disorders among fibromyalgia patients
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 25, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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