The Effect of Central Sensitization on Treatment Response in Patients With Fibromyalgia

Recruiting

• Conditions: Fibromyalgia; Central Sensitisation
• Interventions: Drug: Duloxetine; Drug: Pregabalin; Drug: Amitriptyline

• Registration Number: NCT05020600
• Lead Sponsor: Marmara University

Brief Summary

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with fibromyalgia has been demonstrated in several studies. However, the effect of initial CS severity on treatment response in these patients is not fully known. In this study, it was aimed to investigate the severity of CS and its effect on treatment response in patients with fibromyalgia.

Detailed Description

Fibromyalgia 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 central sensitization-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 central sensitization in patients with fibromyalgia, strengthen the relationship between fibromyalgia and central sensitization. The central sensitization inventory (CSI) was developed in 2012 to be used in the recognition of central sensitivity syndromes in patients with fibromyalgia. A score of 40 and above is accepted in favor of central sensitization in the scale, which consists of two parts, in which central sensitization-related symptoms and diagnoses are questioned; scores of 30-39 are classified as mild, 40-49 moderate, 50-59 severe, and 60-100 very severe. Parallel to the increase in the CSI score, an increase is observed in patients' pain severity, disability, depressive symptoms and sleep disorders.In addition, it has been reported in the literature that factors such as pre-treatment pain severity and depression affect the treatment response.Considering all these factors, it is possible that there is a relationship between the severity of central sensitization and treatment response in patients with fibromyalgia.Based on this, in this study, it was aimed to investigate the effect of central sensitization severity, which was evaluated with CSI before treatment, on the treatment process.

Study Timeline

• Study First Submitted: 2021-08-18
• Study Start: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Status Verified: 2022-11
• Last Update Submitted: 2023-08-12
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with fibromyalgia	Duloxetine	Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
Patients with fibromyalgia	Pregabalin	Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
Patients with fibromyalgia	Amitriptyline	Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria

Primary Outcome Measures

Name	Time	Method
Symptom severity scale	2 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
Fibromyalgia impact scale	2 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	2 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')
Short Form-36	2 year	Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.
Central sensitization inventory	2 year	Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Trial Locations

Locations (1)

Feyza Nur YUCEL; 🇹🇷 İstanbul, Turkey