Clinical Trials Directory

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UnknownNCT05020600

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Marmara University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDuloxetineFirst-line fibromyalgia treatment
DRUGPregabalinFirst-line fibromyalgia treatment
DRUGAmitriptylineFirst-line fibromyalgia treatment

Timeline

Start date
2021-08-19
Primary completion
2024-06-01
Completion
2024-12-01
First posted
2021-08-25
Last updated
2023-08-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05020600. Inclusion in this directory is not an endorsement.