Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03531385
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated 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
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531385


Contacts
Layout table for location contacts
Contact: Koray Ayar, 1 +902242955000 ext 1652 ayarkoray@hotmail.com
Contact: Burcu Okmen, 2 +902242955000 burcumetinokmen@gmail.com

Locations
Layout table for location information
Turkey
Bursa Yüksek İhtisas Education and Research Hospital Recruiting
Bursa, Turkey, 16230
Contact: koray Ayar    +902242955000    ayarkoray@hotmail.com   
Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital

Additional Information:

Layout table for additonal information
Responsible Party: Koray Ayar, Assistant Professor, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03531385     History of Changes
Other Study ID Numbers: 2011-KAEK-25 2018/03-12
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Layout table for additional information
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:
Layout table for MeSH terms
Neuralgia
Behcet Syndrome
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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