Clinical trial NCT05020600: The Effect of Central Sensitization on Treatment Response in Patients With Fibromyalgia
Official title: Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Sensitisation
Fibromyalgia
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fibromyalgia patients

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.

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

Primary outcomes:
measure: Visual analog scale ( VAS) pain
timeFrame: 2 year
measure: Symptom severity scale
timeFrame: 2 year
measure: Fibromyalgia impact scale
timeFrame: 2 year
measure: Short Form-36
timeFrame: 2 year
measure: Central sensitization inventory
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Feyza Nur YUCEL
Study officials:
affiliation: Marmara University
name: Canan SANAL TOPRAK, assoc. prof.
role: STUDY_DIRECTOR
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