NCT05941780

Pain Phenotypes in Patients With Fibromyalgia Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia, Primary
• Fibromyalgia
• Chronic Pain Syndrome
• Pain, Neuropathic
• Nociceptive Pain
• Central Sensitisation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pain classification method	A current clinical algorithm will be used to determine the predominant type of pain in individuals with FMS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers.

Timeline

• Start date: 2023-07-10
• Primary completion: 2023-11-28
• Completion: 2025-01-30
• First posted: 2023-07-12
• Last updated: 2026-03-30

Locations

1 site across 1 country: Turkey (Türkiye)