- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531385
Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease
July 10, 2019 updated by: Koray Ayar, Bursa Yüksek İhtisas Education and Research Hospital
Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease and Healthy Controls
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bursa, Turkey, 16230
- Bursa Yüksek İhtisas Education and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Behcet
Patients diagnosed with Behcet disease
|
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.
Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire
Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index
Quality of life will be assessed by the Nottingham Health Profile
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Healthy controls
Individuals without any chronic disease
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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.
Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire
Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index
Quality of life will be assessed by the Nottingham Health Profile
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
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6 months
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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.
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6 months
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Nottingham Health Profile
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2018
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
March 21, 2019
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
May 9, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
July 11, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Skin Diseases
- Eye Diseases
- Pain
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Peripheral Nervous System Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Behcet Syndrome
- Neuralgia
Other Study ID Numbers
- 2011-KAEK-25 2018/03-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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