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Assessment of Psychological Symptoms Among Fibromyalgia Patients

Primary Purpose

Psychological Symptoms in Fibromyalgia Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repitetive transcranial magnetic stimulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Symptoms in Fibromyalgia Patients

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Fibromyalgia patients with use of rtms sessions for treatment

    Fibromyalgia pt with use of sphenopalatine ganglion block as treatment

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2022
    Last Updated
    September 25, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05557500
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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].
    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Symptoms in Fibromyalgia Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fibromyalgia patients with use of rtms sessions for treatment
    Arm Type
    Experimental
    Arm Description
    Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions
    Arm Title
    Fibromyalgia pt with use of sphenopalatine ganglion block as treatment
    Arm Type
    Experimental
    Arm Description
    Pain killing intervention for pain control of myofacial pain in fibromyalgia patients
    Intervention Type
    Device
    Intervention Name(s)
    Repitetive transcranial magnetic stimulation
    Intervention Description
    Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions
    Primary Outcome Measure Information:
    Title
    Evaluate prevelance of psychiatric disorders among fibromyalgia patients
    Description
    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
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hossameldin Khalifa
    Phone
    01006266237
    Email
    hossamkhalifa71@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abdelbaki
    Phone
    01096477803
    Email
    ahmedbaki2020@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18576297
    Citation
    Bigatti SM, Hernandez AM, Cronan TA, Rand KL. Sleep disturbances in fibromyalgia syndrome: relationship to pain and depression. Arthritis Rheum. 2008 Jul 15;59(7):961-7. doi: 10.1002/art.23828.
    Results Reference
    background
    PubMed Identifier
    24737367
    Citation
    Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
    Results Reference
    background
    PubMed Identifier
    14558098
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16078356
    Citation
    Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21. Erratum In: J Rheumatol Suppl. 2005 Oct;32(10):2063.
    Results Reference
    background
    PubMed Identifier
    7818567
    Citation
    Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
    Results Reference
    background
    PubMed Identifier
    11097099
    Citation
    Lindell L, Bergman S, Petersson IF, Jacobsson LT, Herrstrom P. Prevalence of fibromyalgia and chronic widespread pain. Scand J Prim Health Care. 2000 Sep;18(3):149-53. doi: 10.1080/028134300453340.
    Results Reference
    background
    PubMed Identifier
    18176867
    Citation
    Sarzi-Puttini P, Atzeni F, Di Franco M, Lama N, Batticciotto A, Iannuccelli C, Dell'Acqua D, de Portu S, Riccieri V, Carrabba M, Buskila D, Doria A, Valesini G. Anti-polymer antibodies are correlated with pain and fatigue severity in patients with fibromyalgia syndrome. Autoimmunity. 2008 Feb;41(1):74-9. doi: 10.1080/08916930701620035.
    Results Reference
    background
    PubMed Identifier
    11346329
    Citation
    Katon W, Sullivan M, Walker E. Medical symptoms without identified pathology: relationship to psychiatric disorders, childhood and adult trauma, and personality traits. Ann Intern Med. 2001 May 1;134(9 Pt 2):917-25. doi: 10.7326/0003-4819-134-9_part_2-200105011-00017.
    Results Reference
    background
    PubMed Identifier
    2238278
    Citation
    [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.
    Results Reference
    background
    PubMed Identifier
    16753335
    Citation
    Andre-Obadia N, Peyron R, Mertens P, Mauguiere F, Laurent B, Garcia-Larrea L. Transcranial magnetic stimulation for pain control. Double-blind study of different frequencies against placebo, and correlation with motor cortex stimulation efficacy. Clin Neurophysiol. 2006 Jul;117(7):1536-44. doi: 10.1016/j.clinph.2006.03.025. Epub 2006 Jun 5.
    Results Reference
    background
    PubMed Identifier
    15935625
    Citation
    Graff-Guerrero A, Gonzalez-Olvera J, Fresan A, Gomez-Martin D, Mendez-Nunez JC, Pellicer F. Repetitive transcranial magnetic stimulation of dorsolateral prefrontal cortex increases tolerance to human experimental pain. Brain Res Cogn Brain Res. 2005 Sep;25(1):153-60. doi: 10.1016/j.cogbrainres.2005.05.002.
    Results Reference
    background
    PubMed Identifier
    15351448
    Citation
    Summers J, Johnson S, Pridmore S, Oberoi G. Changes to cold detection and pain thresholds following low and high frequency transcranial magnetic stimulation of the motor cortex. Neurosci Lett. 2004 Sep 23;368(2):197-200. doi: 10.1016/j.neulet.2004.07.008.
    Results Reference
    background
    PubMed Identifier
    19201092
    Citation
    Valmunen T, Pertovaara A, Taiminen T, Virtanen A, Parkkola R, Jaaskelainen SK. Modulation of facial sensitivity by navigated rTMS in healthy subjects. Pain. 2009 Mar;142(1-2):149-58. doi: 10.1016/j.pain.2008.12.031. Epub 2009 Feb 6.
    Results Reference
    background
    PubMed Identifier
    19822394
    Citation
    Nahmias F, Debes C, de Andrade DC, Mhalla A, Bouhassira D. Diffuse analgesic effects of unilateral repetitive transcranial magnetic stimulation (rTMS) in healthy volunteers. Pain. 2009 Dec 15;147(1-3):224-32. doi: 10.1016/j.pain.2009.09.016. Epub 2009 Oct 12.
    Results Reference
    background

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    Assessment of Psychological Symptoms Among Fibromyalgia Patients

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