About this trial
Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria
Female patients aged 18-65
Being literate
Having signed the informed consent form upon agreeing to participate in the study
Disqualifiers
Being under 18 or over 65 years of age
Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)
Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)
Peripheral artery disease
Trial population
The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Quantitative Sensory Tests(QST) protocol
Other interventionincluding PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
Clinical Scales
Other interventionCentral Sensitization Inventory, Revised Fibromyalgia Impact Questionnaire, S-LANSS, Tampa Kinesiophobia Scale, Hospital Anxiety and Depression Scale, SF-12 Quality of Life Scale and Fatigue Severity Scale
Treatment groups
Trial outcomes
Primary outcomes
Conditioned Pain Modulation
Objective determination of the pain modulation phenotype and the severity of central sensitization. Scores above 100 are considered a normal CPM response; higher scores indicate greater pain inhibition.
Secondary outcomes
Pressure Pain Threshold
Lower values are associated with pain sensitization
Slowly Repeated Evoked Pain Assessment Protocol
The SREP protocol consists of 9 painful stimuli above the pain threshold, each applied to the nail for 5 seconds at approximately 30-second intervals.
Central Sensitization Inventory
It is preferred for investigating pain sensitivity through symptoms associated with CS and related comorbidities. CS severity can be classified into 5 different groups based on the score obtained from Section A of the scale: scores of 0-21 indicate a subclinical level, 22-30 indicate a mild level, 31-37 indicate a moderate level, 38-51 indicate a severe level, and scores above 51 indicate a very severe level of CS .
Revised Fibromyalgia Impact Questionnaire
It consists of three sections-daily physical activities, general condition, and symptoms-and a total of 21 questions. It assesses limitations and functional disability in patients with fibromyalgia. All questions are rated on a 0-10-point Visual Analog Scale (VAS). A higher total score indicates an increase in disability associated with fibromyalgia.
Locations
Sponsors and contacts
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