Central Sensitization, Fibromyalgia (FM), Pain Perception, PRESSURE PAIN THRESHOLD, Quantitative Sensory Testing
Conditions
Keywords
Fibromyalgia, Pain sensitization, Conditioned pain modulation
Brief summary
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.
Detailed description
Fibromyalgia is characterized by altered pain processing mechanisms, including impaired descending pain inhibition and central sensitization. Although both mechanisms have been independently associated with symptom severity and functional impairment, their interrelationship and relative contributions to disease impact are not fully understood. This study aims to examine the associations between conditioned pain modulation, central sensitization symptoms, and fibromyalgia impact. In particular, the study evaluates whether central sensitization symptoms act as a mediator in the relationship between impaired pain modulation and clinical disease burden. Participants with fibromyalgia are assessed using standardized clinical and psychological measures, including the Fibromyalgia Impact Questionnaire, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale. Quantitative sensory testing is performed to evaluate conditioned pain modulation, pressure pain threshold, and temporal summation.Statistical analyses are conducted to explore bivariate associations and to identify independent predictors of fibromyalgia impact. A mediation framework is applied to assess whether central sensitization symptoms explain the relationship between pain modulation and clinical outcomes.
Interventions
OTHERQuantitative Sensory Tests(QST) protocol
including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol
OTHERClinical Scales
Central 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
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria 2. Female patients aged 18-65 3. Being literate 4. Having signed the informed consent form upon agreeing to participate in the study
Exclusion criteria
1. Being under 18 or over 65 years of age 2. Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.) 3. Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…) 4. Peripheral artery disease 5. Severe cardiopulmonary insufficiency (stage 3-4) 6. Uncontrolled systemic diseases such as hypertension and diabetes 7. Presence of an active infection 8. Pregnancy 9. Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditioned Pain Modulation | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Pressure Pain Threshold | Baseline | Lower values are associated with pain sensitization |
| Slowly Repeated Evoked Pain Assessment Protocol | Baseline | 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 | Baseline | 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 | Baseline | 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. |
| Self-administered Leeds Assessment of Neuropathic Symptoms and Signs | Baseline | The Neuropathic Symptoms and Signs Questionnaire is a 7-item self-report questionnaire completed by the individual, scored on a scale of 0 to 24. A score of 12 or higher indicates the likelihood of neuropathic pain . |
| Tampa Kinesiophobia Scale | Baseline | A 17-item questionnaire developed to measure the fear of movement and re-injury . The total score ranges from 17 to 68. Higher scores are associated with an increase in kinesiophobia. |
| Hospital Anxiety and Depression Scale | Baseline | It consists of a total of 14 items, with 7 items each for anxiety and depression. Scores for the anxiety and depression subscales range from 0 to 21. Scores between 8 and 10 indicate moderate symptom presence, while a score greater than 11 indicates anxiety and depression symptoms that likely correspond to a clinical diagnosis. |
| SF-12 Quality of Life Scale | Baseline | It was developed to assess health-related quality of life. Two separate scores are obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The physical score reflects the individual's perception of overall health, physical limitations, and pain levels. The mental score, on the other hand, reflects the individual's emotional problems, energy levels, and social activities. |
| Fatigue Severity Scale | Baseline | This is a 9-item questionnaire in which each item is rated on a scale of 1 to 7; it assesses the severity, frequency, and impact of fatigue on daily life. The total score ranges from 7 to 63. As the score decreases, fatigue decreases. |
Contacts
CONTACTFeyza Nur Yücel, Assoc. Prof.
PRINCIPAL_INVESTIGATORFeyza Nur Yücel, Assoc. Prof.
Saglik Bilimleri Universitesi
Outcome results
None listed