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Status unknownNCT05557500Updated Sep 28, 2022

Assessment of Psychological Symptoms Among Fibromyalgia Patients

An interventional study of Repitetive transcranial magnetic stimulation in Psychological Symptoms in Fibromyalgia Patients, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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].

Read the 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 .

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Conditions studied

  • Psychological Symptoms in Fibromyalgia Patients
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In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceRepitetive transcranial magnetic stimulation

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 18576297 ↗
  • Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266. PubMed 24737367 ↗
  • 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. PubMed 14558098 ↗
  • 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. PubMed 16078356 ↗
  • 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. PubMed 7818567 ↗
  • 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. PubMed 11097099 ↗
  • 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. PubMed 18176867 ↗
  • 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. PubMed 11346329 ↗
  • [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. PubMed 2238278 ↗
  • 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. PubMed 16753335 ↗
  • 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. PubMed 15935625 ↗
  • 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. PubMed 15351448 ↗
  • 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. PubMed 19201092 ↗
  • 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. PubMed 19822394 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05557500
Lead sponsor
Assiut University
Responsible party
CA Adeeb (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 28, 2022
Start date
Sep 25, 2022 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Sep 28, 2022

Study contacts

Hossameldin Khalifa
Contact
hossamkhalifa71@aun.edu.eg
01006266237
Ahmed Abdelbaki
Contact
ahmedbaki2020@yahoo.com
01096477803

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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