Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03531385
Other study ID # 2011-KAEK-25 2018/03-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 22, 2018
Est. completion date March 21, 2019

Study information

Verified date July 2019
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 21, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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.
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
Quality of life
Quality of life will be assessed by the Nottingham Health Profile

Locations

Country Name City State
Turkey Bursa Yüksek Ihtisas Education and Research Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain Detect Questionaire 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%). 6 months
Secondary Pittsburgh Sleep Quality Index 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. 6 months
Secondary Nottingham Health Profile 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. 6 months
See also
  Status Clinical Trial Phase
Completed NCT06139120 - The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome
Completed NCT05062694 - Physical Therapy Management Of The Patient With Central Sensitization
Not yet recruiting NCT05986513 - Brain MRI for Knee OA N/A
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Completed NCT05559021 - What Concept of Manual Therapy is More Effective? N/A
Completed NCT04485078 - Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
Completed NCT05162664 - Presence of Signs of Central Sensitization in Episodic and Chronic Migraine N/A
Recruiting NCT06043141 - Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome
Completed NCT06336278 - Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis
Terminated NCT05022251 - Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Completed NCT04361149 - Motor Unit Abnormalities After Experimentally Induced Sensitization Phase 4
Completed NCT05146960 - Relation Between Temporal Summation and Fatigue N/A
Completed NCT04043962 - Mechanisms Of Change in Adolescent Pain Self-management N/A
Completed NCT03863808 - Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization N/A
Active, not recruiting NCT05169918 - Sensorial Discrimination in Chronic Low Back Pain N/A
Recruiting NCT06169917 - Pain Processing In Relation To Breathing N/A
Not yet recruiting NCT06367998 - Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT05932433 - Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients. N/A
Completed NCT05381012 - Fibromyalgia Syndrome on Patients With Chronic Migraine N/A
Completed NCT05031286 - Differences in Pain Processing Between Men and Women N/A