The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia

Conditions
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Central Sensitisation, Fibromyalgia, Neuropathic Pain

Intervention / Treatment
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* Diagnostic Test: Central sensitization inventory
* Diagnostic Test: Widespread pain index
* Diagnostic Test: Symptom severity scale
* Other: Fibromyalgia impact questionnaire
* Diagnostic Test: Hospital Anxiety and Depression Scale
* Diagnostic Test: Self-Leeds Assessment of Neuropathic Symptoms and Signs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with fibromyalgia<br>Patients diagnosed with FM according to ACR 2016 criteria | Diagnostic Test: Central sensitization inventory<br>* Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.<br>* Other names: CSI;Diagnostic Test: Widespread pain index<br>* Total the number of painful body areas<br>* Other names: WPI;Diagnostic Test: Symptom severity scale<br>* The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms<br>* Other names: SSS;Other: Fibromyalgia impact questionnaire<br>* A tool to assess health status in fibromyalgia<br>* Other names: FIQ;Diagnostic Test: Hospital Anxiety and Depression Scale<br>* An instrument for detecting depression and anxiety<br>* Other names: HADS;Diagnostic Test: Self-Leeds Assessment of Neuropathic Symptoms and Signs<br>* An instrument used to identify pain of neuropathic origin<br>* Other names: S-LANSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |