Trials / Completed

CompletedNCT04485078

Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients

The Clinical and the Functional Impact of Central Sensitization On Patients With Axial Spondyloarthritis

Status: Completed
Phase: —
Study type: Observational
Enrollment: 150 (actual)

Sponsor: Marmara University · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Accepted

Summary

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 (CPM).Pressure 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

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pressure pain threshold	The PPT assessments of spine will be performed over the spinous process and 2 cm right and left side of the corresponding spinous process. The regional PPT scores will be composed from sum of all PPT values for related segments at spine. The sacroiliac PPT scores will be obtained bilaterally from four measurement points; the first point is located 1 cm medially and caudally from spina iliaca posterior superior (SIPS) and 3 more laterally, medially and cranially.The left trapezius muscle will be used to evaluate distant control point .The 1 cm2 algometer probe will be placed vertically in the each selected point and pressure will be increased with 0.1 kg/sc until the participant reporting pressure became painful. The pressure value at which the pain is first felt will be accepted as the PPT of that point.
DIAGNOSTIC_TEST	Temporal summation	TS will be evaluated over the trapezius muscle, sacroiliac joints, C7, T6, and L3 levels at spine with manuel algometer. TS scores will be calculated for each spine level as the sum of three values which measured over the spinous process and 2 cm right and left side of corresponding level. In the evaluation of TS, a pressure as much the PPT value of each point will be applied with pain pressure algometer ten times with a 1-second interstimulus interval. Patients will be asked to rate their pain using on a 0 to 10 visual analogue scale (VAS) at 0, 5, and 10 seconds. TS will be calculated by subtracting the rating at 0 seconds from the rating at 10 seconds. The point that is located 1 cm medially and caudally from SIPS was used for SI joint TS measurement on both sides.
DIAGNOSTIC_TEST	Conditioned pain modulation	First stimulus will be applied to trapezius with the pressure that induced a pain intensity of 4 point on a 10 point VAS as called a test stimulus. After that the right hand of the patient will be immersed in 70C water for 20 seconds to create a conditioning stimulus. Second test stimulus with the same intensity of first one will be applied to trapezius after the conditioning stimulus and patients will be asked to rate their pain. If the patients cannot hold their hand in the water for 20 seconds, the test stimulus will be applied immediately after the patients removed their hands out of water. The ratio between the first and second VAS values multiplied by 100 will be defined as CPM score
DIAGNOSTIC_TEST	Central Sensitization Inventory	Standardized questionnaire to determine the level of central sensitization
OTHER	Bath Ankylosing Spondylitis Disease Activity Index	Standardized questionnaire to determine the level of disease activity in AxSpa patients
OTHER	Ankylosing Spondylitis Quality of Life	Standardized questionnaire to investigate the quality of life in AxSpa patients
OTHER	Istanbul Low Back Pain Disability Index	Standardized questionnaire to investigate the disability
OTHER	Beck Depression Inventory	Standardized questionnaire to investigate the depression
OTHER	Fatigue Severity Scale	Standardized questionnaire to investigate the fatigue
OTHER	Pittsburgh Sleep Quality Index	Standardized questionnaire to investigate the sleep quality and disturbance
OTHER	Fibromyalgia Rapid Screening Tool	Standardized questionnaire to detect fibromyalgia
OTHER	Visual analogue scale	global pain score on a 0 to 10

Timeline

Start date: 2019-10-20
Primary completion: 2020-02-14
Completion: 2020-04-18
First posted: 2020-07-24
Last updated: 2020-08-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04485078. Inclusion in this directory is not an endorsement.