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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05701696
Other study ID # 22/640
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 16, 2023
Est. completion date November 30, 2023

Study information

Verified date January 2023
Source Marmara University
Contact Feyza Nur Yücel, MD
Phone 5385577059
Email dr.fny28@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fibromyalgia (FM) is the prototype of a group of diseases known as central sensitivity syndromes, whose relationship with pain sensitization is well defined. Central sensitization (CS) is also one of the mechanisms involved in the pathophysiology of neuropathic pain. Neuropathic pain, which is a common complaint in FM patients, is likely to be one of the clinical manifestations of central sensitization. Therefore, in this study, it was aimed to investigate the relationship between CS and neuropathic pain.


Description:

The term central sensitization (CS) was first used by Wolf in 1988 and explained as an increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. Fibromyalgia (FM) is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown. It is considered to be the main member of the CS related disease group known as central sensitivity syndromes with impaired pain regulation. In various studies, hyperalgesia and allodynia, which are accepted as objective findings of CS in pain sensitization. In addition to widespread body pain, neuropathic pain is one of the common symptoms in FM, and various studies have shown a significant increase in neuropathic pain in FM patients compared to healthy controls. It is known that CS is one of the basic mechanisms in the etiopathogenesis of neuropathic pain as well as its role in FM. In a study of FM patients, painDETECT and S-LANSS scores were found to be correlated with CSI scores, and the authors emphasized the relationship between pain sensitization and neuropathic complaints in these patients. CS seems likely to be one of the neuropathic pain mechanisms in FM patients, and the available data seem insufficient to draw a definitive conclusion. From this point of view, in this study, it was aimed to investigate the relationship between the presence and severity of CS and the neuropathic pain component of the disease in patients with FM.


Recruitment information / eligibility

Status Recruiting
Enrollment 111
Est. completion date November 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosing fibromyalgia according to ACR 2016 criteria - Between the ages of 18-65 - Agree to participate in the study Exclusion Criteria: - History of concomitant systemic inflammatory disease, active infection and malignancy - Refusing to participate in the study - Polyneuropathy, entrapment neuropathy, and radiculopathy are other diagnosed sources of neuropathic pain.

Study Design


Intervention

Diagnostic Test:
Central sensitization inventory
Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.
Widespread pain index
Total the number of painful body areas
Symptom severity scale
The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms
Other:
Fibromyalgia impact questionnaire
A tool to assess health status in fibromyalgia
Diagnostic Test:
Hospital Anxiety and Depression Scale
An instrument for detecting depression and anxiety
Self-Leeds Assessment of Neuropathic Symptoms and Signs
An instrument used to identify pain of neuropathic origin

Locations

Country Name City State
Turkey University of Health Sciences Istanbul Uskudar

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6. — View Citation

Bhargava J, Hurley JA. Fibromyalgia. 2022 Oct 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540974/ — View Citation

Martinez-Lavin M. Fibromyalgia in women: somatisation or stress-evoked, sex-dimorphic neuropathic pain? Clin Exp Rheumatol. 2021 Mar-Apr;39(2):422-425. doi: 10.55563/clinexprheumatol/0c7d6v. Epub 2020 Sep 16. — View Citation

Pomares FB, Funck T, Feier NA, Roy S, Daigle-Martel A, Ceko M, Narayanan S, Araujo D, Thiel A, Stikov N, Fitzcharles MA, Schweinhardt P. Histological Underpinnings of Grey Matter Changes in Fibromyalgia Investigated Using Multimodal Brain Imaging. J Neurosci. 2017 Feb 1;37(5):1090-1101. doi: 10.1523/JNEUROSCI.2619-16.2016. Epub 2016 Dec 16. — View Citation

Ubeda-D'Ocasar E, Valera-Calero JA, Gallego-Sendarrubias GM, Fernandez-de-Las-Penas C, Arias-Buria JL, Morales-Cabezas M, Arendt-Nielsen L, Cigaran-Mendez M. Association of Neuropathic Pain Symptoms with Sensitization Related Symptomatology in Women with Fibromyalgia. Biomedicines. 2022 Mar 6;10(3):612. doi: 10.3390/biomedicines10030612. — View Citation

Woolf CJ, Thompson SW, King AE. Prolonged primary afferent induced alterations in dorsal horn neurones, an intracellular analysis in vivo and in vitro. J Physiol (Paris). 1988-1989;83(3):255-66. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CSI Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization. 1 year
Primary S-LANSS Questionnaire used to investigate the neuropathic character of pain. A score =12 points suggests the presence of pain of neuropathic origin 1 year
Secondary Visual analog scale ( VAS) pain Pain rating scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') 1 year
Secondary Fibromyalgia impact scale The questionnaire was developed to determine the degree of being affected by the disease in patients with a diagnosis of fibromyalgia.The scale consists of 10 parts in total, and the first part is a Likert scale containing 11 questions. High scores indicate that the patient is overly affected. 1 year
Secondary Symptom severity scale The SS scale quantifies symptom severity on a 0-12 scale by scoring problems with fatigue, cognitive dysfunction and unrefreshed sleep over the past week. SSI = 5 favors fibromyalgia. 1 year
Secondary Widespread pain index In this scale, the areas with pain in the last 7 days are marked from a total of 5 regions, including the right and left upper region, the right and left lower region, and the axial region. The total score is between 0-19, and YAS = 7 points is significant for the diagnosis of fibromyalgia. 1 year
Secondary HADS The scale consists of 14 questions, 7 of which are anxiety and 7 are depression.More than 10 points for anxiety and 7 points for depression are considered significant. 1 year
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