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

• ClinicalTrials.gov Identifier: NCT03531385
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: July 11, 2019
• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Information provided by (Responsible Party): Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Behcet's Disease; Central Sensitisation	Diagnostic Test: Central sensitisation; Diagnostic Test: Neuropathic pain; Other: Sleep disturbance; Other: Quality of life

Detailed Description:

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Official Title: Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease and Healthy Controls
• Actual Study Start Date: May 22, 2018
• Actual Primary Completion Date: February 1, 2019
• Actual Study Completion Date: March 21, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Behcet; Patients diagnosed with Behcet disease	Diagnostic Test: 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.; Diagnostic Test: Neuropathic pain; Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire; Other: Sleep disturbance; Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index; Other: Quality of life; Quality of life will be assessed by the Nottingham Health Profile
Healthy controls; Individuals without any chronic disease	Diagnostic Test: 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.; Diagnostic Test: Neuropathic pain; Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire; Other: Sleep disturbance; Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index; Other: Quality of life; Quality of life will be assessed by the Nottingham Health Profile

Outcome Measures

Primary Outcome Measures :

1. Central Sensitisation Inventory [ Time Frame: 6 months ]
   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

Secondary Outcome Measures :

1. Pain Detect Questionaire [ Time Frame: 6 months ]
   The pain detect questionnaire was specifically developed to detect neuropathic pain components in adult patients. The questionnaire consists of seven questions that address the quality of neuropathic pain symptoms; it is completed by the patient and no physical examination is required. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of <13 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of 19 < suggests that pain is likely to have a neuropathic component (> 90%).
2. Pittsburgh Sleep Quality Index [ Time Frame: 6 months ]
   It is composed of 19 questions, which create 7 major components. Each component is scored from 0 to 3 points, in which lower point denotes no problems, while higher score denotes worsening problems in following order: (1) subjective sleep quality (very good vs. very bad), (2) sleep latency (≤15 min to >60 min), (3) sleep duration (≥7 h to <5 h), (4) sleep efficiency (≥85% to <65% h sleep/hours in bed), (5) sleep disturbances (not during the past month to ≥3 times per week), (6) use of sleeping medications (none to ≥3 times a week) and (7) daytime dysfunction (not a problem to a very big problem). All 7 components are then summed up to create a scale from 0 to 21 points.
3. Nottingham Health Profile [ Time Frame: 6 months ]
   Health related quality of life of the patients was evaluated with the Nottingham Health Profile, which contains 38 items in 6 domains related to level of energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), physical mobility (8 items), and social isolation (5 items). Items in each domain are assigned a weight; the total score for each domain is 100; a score of 0 indicates good subjective health status, while 100 indicates poor subjective health status. Total Nottingham Health Profile total score is obtained by averaging the 6 domain scores.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

Criteria

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

Contacts and Locations

Locations

Turkey

Bursa Yüksek İhtisas Education and Research Hospital

Bursa, Turkey, 16230

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

More Information

Additional Information:

• Responsible Party: Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT03531385
• Other Study ID Numbers: 2011-KAEK-25 2018/03-12
• First Posted: May 21, 2018
• Last Update Posted: July 11, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital:

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

Additional relevant MeSH terms:

Behcet Syndrome; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases; Skin Diseases, Vascular