Psychological Symptoms in Fibromyalgia PatientsNCT05557500
Assessment of Psychological Symptoms Among Fibromyalgia Patients
A study testing Repitetive transcranial magnetic stimulation in people with Psychological Symptoms in Fibromyalgia Patients, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Psychological Symptoms in Fibromyalgia Patients
- What is being tested?
- Repitetive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 18 to 60 years old Diagnosed as fibromyalgia with resistence to pharmacological treatment
Who cannot join
- Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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].
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 .
- Being tested
- Repitetive transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repitetive transcranial magnetic stimulationDevice
Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia patients with use of rtms sessions for treatment | Experimental | Repitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions Receives: Device: Repitetive transcranial magnetic stimulation |
| Fibromyalgia pt with use of sphenopalatine ganglion block as treatment | Experimental | Pain killing intervention for pain control of myofacial pain in fibromyalgia patients Receives: Device: Repitetive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Psychological Symptoms in Fibromyalgia PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CA Adeeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557500
- Sponsor's protocol ID
- APF
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 18576297Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
PubMed 24737367Giesecke 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 14558098Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21.
PubMed 16078356Wolfe 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 7818567Lindell 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 11097099Sarzi-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 18176867Katon 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 2238278Andre-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 16753335Graff-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 15935625Summers 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 15351448Valmunen 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 19201092Nahmias 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Psychological Symptoms and Quality if Life Among Fibromyalgia Patients and Its Risk Factors
- ClinicalTrials.gov ID
- NCT05557500
- Acronym / sponsor ID
- APF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia patients with use of rtms sessions for treatment | Experimental | Device: Repitetive transcranial magnetic stimulationRepitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions |
| Fibromyalgia pt with use of sphenopalatine ganglion block as treatment | Experimental | Device: Repitetive transcranial magnetic stimulationPain killing intervention for pain control of myofacial pain in fibromyalgia patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged from 18 to 60 years old Diagnosed as fibromyalgia with resistence to pharmacological treatment
Key exclusion criteria (1 listed)
- Previous psychiatric disorders Sever cognitive dysfunction Other medical or neurological disorders Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repitetive transcranial magnetic stimulationRepitetive transcranial magnetic stimulation on primary motor area with 20 HZ for 20 sessions | Device | Fibromyalgia patients with use of rtms sessions for treatment, Fibromyalgia pt with use of sphenopalatine ganglion block as treatment |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 18576297Bigatti 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.
- Background: PubMed 24737367Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
- Background: PubMed 14558098Giesecke 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.
- Background: PubMed 16078356Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21.
- Background: PubMed 7818567Wolfe 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.
- Background: PubMed 11097099Lindell 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.
- Background: PubMed 18176867Sarzi-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.
- Background: PubMed 11346329Katon 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.
- Background: PubMed 2238278[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.
- Background: PubMed 16753335Andre-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.
- Background: PubMed 15935625Graff-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.
- Background: PubMed 15351448Summers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Repitetive transcranial magnetic stimulation in people with Psychological Symptoms in Fibromyalgia Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossameldin Khalifa (01006266237, hossamkhalifa71@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate prevelance of psychiatric disorders among fibromyalgia patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557500, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.