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Clinical trial

Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia

ID
Name
09.2021.117
Description
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.
Trial arms
Trial start
2021-08-19
Estimated PCD
2024-06-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Duloxetine
First-line fibromyalgia treatment
Arms:
Patients with fibromyalgia
Other names:
Dyloxia
Pregabalin
First-line fibromyalgia treatment
Arms:
Patients with fibromyalgia
Other names:
Lyrica
Amitriptyline
First-line fibromyalgia treatment
Arms:
Patients with fibromyalgia
Other names:
Laroxyl
Size
40
Primary endpoint
Visual analog scale ( VAS) pain
2 year
Symptom severity scale
2 year
Fibromyalgia impact scale
2 year
Short Form-36
2 year
Central sensitization inventory
2 year
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-08-15

1 organization

3 products

2 indications

Organization
Marmara University
Product
Duloxetine
Indication
Central Sensitization
Indication
Fibromyalgia
Product
Pregabalin
Product
Amitriptyline