An observational study in Central Sensitisation and Fibromyalgia, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by Marmara University · Observational
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.
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Fibromyalgia patients
Exclusion Criteria:
Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
Drug: Duloxetine · Drug: Pregabalin · Drug: Amitriptyline
First-line fibromyalgia treatment
Also known as: Dyloxia
First-line fibromyalgia treatment
Also known as: Lyrica
First-line fibromyalgia treatment
Also known as: Laroxyl
Visual analog scale ( VAS) pain
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')
Time frame: 2 year
Symptom severity scale
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
Time frame: 2 year
Fibromyalgia impact scale
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.
Time frame: 2 year
Short Form-36
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.
Time frame: 2 year
Central sensitization inventory
Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.
Time frame: 2 year
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Marmara University