Clinical trial NCT05941780: Pain Phenotypes in Patients with Fibromyalgia Syndrome
Official title: Pain Phenotypes in Patients with Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia, Primary
Fibromyalgia
Chronic Pain Syndrome
Pain, Neuropathic
Nociceptive Pain
Central Sensitisation
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with FMS who apply to Pamukkale University Rheumatology Clinic will be screened for eligibility by their clinic physicians and will then be asked to participate in this study

Brief summary: Fibromyalgia Syndrome (FMS); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. It has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. Despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients.

The primary aim of this study is to determine the chronic pain phenotypes in individuals with FMS. The secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with FMS in terms of pain severity, disease severity, quality of life and catastrophe.


Eligibility criteria: Inclusion Criteria:

* being diagnosed with fibromyalgia syndrome according to the criteria of the American Rheumatology Association ,
* not receiving active treatment related to physiotherapy,
* volunteering to participate in the study

Exclusion Criteria:

* diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
* severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
* illiterate
* problems with hearing and vision

Primary outcomes:
measure: Quantitative sensory test: static tactile mechanical threshold
timeFrame: 10 minutes
measure: Quantitative sensory test: hot-cold pain threshold
timeFrame: 5 minutes
measure: Quantitative sensory test: static mechanical allodynia
timeFrame: 5 minutes
measure: Quantitative sensory test: dynamic mechanical allodynia
timeFrame: 5 minutes
measure: Quantitative sensory test: vibration sense
timeFrame: 5 minutes
measure: Margolis Pain Diagram
timeFrame: one minute
measure: Numeric pain rating scale
timeFrame: one minute
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: 10 minutes
measure: Short Form 12 (SF-12)
timeFrame: 10 minutes
measure: Pain Catastrophe Scale (PCS)
timeFrame: 10 minutes
measure: The interview
timeFrame: 5 minutes
Secondary outcomes:
measure: Central Sensitization Inventory
timeFrame: 10 minute
measure: Douleur Neuropathique 4 Questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Hospitals
Study officials:
affiliation: Kutahya Health Sciences University
name: Ismail Saracoglu, P.hD.
role: PRINCIPAL_INVESTIGATOR
References: