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
About this trial
This is an interventional treatment trial for Psychological Symptoms in Fibromyalgia Patients
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
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
NCT ID
NCT05557500
First Posted
September 25, 2022
Last Updated
September 25, 2022
Sponsor
Assiut University
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
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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
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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
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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
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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
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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
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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
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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
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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
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Assessment of Psychological Symptoms Among Fibromyalgia Patients
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