Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease

NCT03531385 | Completed

• 1 other identifier: 2011-KAEK-25 2018/03-12
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There are few studies in the literature regarding increased frequency of neuropathic pain and sleep disturbance and decreased quality of life in Behçet's disease. Frequency of central sensitization was not investigated in patients with Behçet's disease before. In this study, it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep disorder and quality of life and their relation to each other in Behcet's disease.

Conditions

Behcet's Disease; Central Sensitisation

Keywords

Behcet's disease; Central sensitisation; Neuropathic pain; Sleep disturbance

Outcome Measures

Primary Outcomes (1)

• Central Sensitisation Inventory

  A self-report inventory, the Central Sensitization Inventory (CSI), will be used to assess the overlapping symptom dimensions of Central Sensitivity Syndromes. This measure is intended as a screening instrument to help identify the presence of a Central Sensitivity Syndrome, and to alert clinicians that presenting symptoms may be related to central sensitisation. Part A of the Central Sensitisation Inventory assesses 25 health-related symptoms that are common to Central Sensitivity Syndrome, with total scores ranging from 0-100. Part B (which is not scored) asks if one has previously been diagnosed with one or more specific disorders, including seven separate Central Sensitivity Syndromes

  6 months

Secondary Outcomes (3)

• Pain Detect Questionaire

  6 months

• Pittsburgh Sleep Quality Index

  6 months

• Nottingham Health Profile

  6 months

Study Arms (2)

Behcet

Patients diagnosed with Behcet disease

Diagnostic Test: Central sensitisation; Diagnostic Test: Neuropathic pain; Other: Sleep disturbance; Other: Quality of life

Healthy controls

Individuals without any chronic disease

Diagnostic Test: Central sensitisation; Diagnostic Test: Neuropathic pain; Other: Sleep disturbance; Other: Quality of life

Interventions

Central sensitisation DIAGNOSTIC_TEST

Central Sensitization Inventory, which is a comprehensive self-report inventory to assess the overlapping symptom dimensions of central sensitisation syndrome will be used to identify participants with central sensitisation.

Behcet; Healthy controls

Neuropathic pain DIAGNOSTIC_TEST

Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire

Behcet; Healthy controls

Sleep disturbance OTHER

Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index

Behcet; Healthy controls

Quality of life OTHER

Quality of life will be assessed by the Nottingham Health Profile

Behcet; Healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consists of participants who are between age 18-75, not pregnant and who were not diagnosed previously with diabetes mellitus or chronic renal failure

You may qualify if:

• Patients diagnosed with Behcet disease according to international study group criteria
• Healthy volunteers without previously known systemic chronic disease
• Patients older than 18
• Patients younger than 75

You may not qualify if:

• Participants which were previously diagnosed with diabetes mellitus
• Participants which were previously diagnosed with chronic renal failure
• Pregnant women

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas Education and Research Hospital

Bursa, 16230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet Syndrome; Neuralgia; Parasomnias

Interventions

Central Nervous System Sensitization; Quality of Life

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 21, 2018
• Study Start: May 22, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 21, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

TU (1)