Clinical trial NCT05701696: The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia
Official title: Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Sensitisation
Fibromyalgia
Neuropathic Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fibromyalgia patients

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: CSI
timeFrame: 1 year
measure: S-LANSS
timeFrame: 1 year
Secondary outcomes:
measure: Visual analog scale ( VAS) pain
timeFrame: 1 year
measure: Fibromyalgia impact scale
timeFrame: 1 year
measure: Symptom severity scale
timeFrame: 1 year
measure: Widespread pain index
timeFrame: 1 year
measure: HADS
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Feyza Nur Yücel, MD
role: PRINCIPAL_INVESTIGATOR
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