Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485078
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-07-21
Brief Title:
Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Clinical and the Functional Impact of Central Sensitization On Patients With Axial Spondyloarthritis
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The term axial spondyloarthritis axSpA describes a group of chronic inflammatory diseases that characterized with spinal involvement AxSpA is one of the most common rheumatic diseases and chronic pain and morning stiffness are the main complaints of these patients Central sensitization is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies Pain in axSpA patients is generally considered as a result of increased inflammatory burden and structural changes However failure to adequate analgesia in every patient whose inflammation is suppressed with anti-inflammatory treatment suggests new pain mechanisms Central sensitization CS is one of these mechanisms and its recognition is only possible by detailed evaluation of the patient There is no method for the diagnosis of central sensitization is accepted as a gold standard clinical scales and quantitative sensory testing QST widely is used for this purpose widely The most commonly used QST types include pressure pain threshold PPT temporal summation TS and conditioned pain modulation CPM The well-known scale used for the evaluation of central sensitization is the Central Sensitization Inventory developed by Mayer etal in 2011 for detect central sensitization in chronic pain patients The aim of this study is to evaluate the frequency of central sensitization CS in patients with axSpA by means of clinical scales and quantitative sensory testing QST to examine related comorbidities and the parameters associated with the development of sensitization in these patients
Detailed Description:
The term axial spondyloarthritis axSpA describes a group of chronic inflammatory diseases that characterized with spinal involvement AxSpA is one of the most common rheumatic diseases and chronic pain and morning stiffness are the main complaints of these patients Central sensitization CS is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies However data associated with central sensitization in axSpA patients is very limited The quantitative sensory testing QST is commonly used for detection hyperalgesia and allodynia those are accepted main findings in sensitized patients The most commonly used QST types include pressure pain threshold PPT temporal summation TS and conditioned pain modulation CPMPressure pain threshold measurement is frequently used to show local generalized sensitivity increase in patients who develop pain sensitization For this purpose the pain response of superficial or deep tissue can be evaluated through mechanical device called algometer The algometer probe was placed vertically in the each selected point and pressure was increased until the participant reporting pressure became painful The first pressure value at which pain is felt is considered the PPT of that point TS is defined as a progressive increase in pain response with repetitive painful stimuli This condition is also known as wind-up phenomenon and play a role to development CS CPM known as one of the main mechanisms of endogenous analgesia is based on the principle that pain perception can be reduced with painful stimulus applied to different areas according to the pain inhibits pain model In the CPM testing it is aimed to investigate the modulator effect of two different painful stimuli on each other The diagnosis of CS can be made with QST or with Central Sensitization Inventory CSI The aim of this study is to evaluate the frequency of central sensitization CS in patients with axial spondyloarthritis AxSpA by means of clinical scales and quantitative sensory testing QST to examine related comorbidities and the parameters associated with the development of sensitization in these patients The patients with AxSpa and healthy controls will be included in this study QST which consists of pressure pain threshold PPT temporal summation TS and conditioned pain modulation CPM will be applied to the patient and control groups Disease activity BASDAI functional status ASQoL ILBPDI sleep quality PSQI pain VAS pain depression BDI and fatigue FSS will be assessed Fibromyalgia FIRST and other comorbidities will be investigated Patients will be divided as the ones with and without CS according to the central sensitization inventory CSI and the results will be compared After data collection analysis will be performed with the appropriate statistical method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None