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

NCT ID: NCT03531385

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2019-03-21

Brief Summary

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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.

Detailed Description

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Central sensitization reduces the pain threshold in the pain pathways of the nervous system, causing pain sensation to be perceived with lower stimuli and often causing chronic pain. Central sensitization can be seen with many conditions such as neuropathic pain and sleep disorders, as well as with inflammatory diseases such as rheumatoid arthritis. 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 patients with Behcet's disease and healthy controls.

Conditions

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Behcet's Disease Central Sensitisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Behcet

Patients diagnosed with Behcet disease

Central sensitisation

Intervention Type 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.

Neuropathic pain

Intervention Type DIAGNOSTIC_TEST

Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire

Sleep disturbance

Intervention Type OTHER

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

Quality of life

Intervention Type OTHER

Quality of life will be assessed by the Nottingham Health Profile

Healthy controls

Individuals without any chronic disease

Central sensitisation

Intervention Type 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.

Neuropathic pain

Intervention Type DIAGNOSTIC_TEST

Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire

Sleep disturbance

Intervention Type OTHER

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

Quality of life

Intervention Type OTHER

Quality of life will be assessed by the Nottingham Health Profile

Interventions

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Central sensitisation

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.

Intervention Type DIAGNOSTIC_TEST

Neuropathic pain

Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire

Intervention Type DIAGNOSTIC_TEST

Sleep disturbance

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

Intervention Type OTHER

Quality of life

Quality of life will be assessed by the Nottingham Health Profile

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Participants which were previously diagnosed with diabetes mellitus
* Participants which were previously diagnosed with chronic renal failure
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Koray Ayar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa Yüksek İhtisas Education and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2018/03-12

Identifier Type: -

Identifier Source: org_study_id

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