The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Recruiting

• Conditions: Fibromyalgia; Neuropathic Pain; Central Sensitisation
• Interventions: 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

• Registration Number: NCT05701696
• Lead Sponsor: Marmara University

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-16
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-08-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with fibromyalgia	Fibromyalgia impact questionnaire	Patients diagnosed with FM according to ACR 2016 criteria
Patients with fibromyalgia	Hospital Anxiety and Depression Scale	Patients diagnosed with FM according to ACR 2016 criteria
Patients with fibromyalgia	Central sensitization inventory	Patients diagnosed with FM according to ACR 2016 criteria
Patients with fibromyalgia	Widespread pain index	Patients diagnosed with FM according to ACR 2016 criteria
Patients with fibromyalgia	Symptom severity scale	Patients diagnosed with FM according to ACR 2016 criteria
Patients with fibromyalgia	Self-Leeds Assessment of Neuropathic Symptoms and Signs	Patients diagnosed with FM according to ACR 2016 criteria

Primary Outcome Measures

Name	Time	Method
S-LANSS	1 year	Questionnaire used to investigate the neuropathic character of pain. A score ≥12 points suggests the presence of pain of neuropathic origin
CSI	1 year	Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Secondary Outcome Measures

Name	Time	Method
Symptom severity scale	1 year	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.
Fibromyalgia impact scale	1 year	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.
Visual analog scale ( VAS) pain	1 year	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')
Widespread pain index	1 year	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.
HADS	1 year	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.

Trial Locations

Locations (1)

University of Health Sciences; 🇹🇷 Istanbul, Uskudar, Turkey