The Relationship Between Magnetic Resonance Imaging (MRI) Scores and Sensory Testing in Axial Spondyloarthritis

Completed

• Conditions: Axial Spondyloarthritis; Inflammation; Central Sensitisation
• Interventions: Diagnostic Test: Pressure pain threshold; Diagnostic Test: Central Sensitization Inventory; Other: Spondyloarthritis Research Consortium of Canada scoring system; Diagnostic Test: Temporal Summation; Diagnostic Test: Conditioned pain modulation

• Registration Number: NCT05021783
• Lead Sponsor: Marmara University

Brief Summary

Axial spondyloarthritis 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. There is no method for the diagnosis of central sensitization is accepted as a gold standard. The 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 (CSI) , developed in 2011 for detect central sensitization in chronic pain patients. In this study, it was aimed to investigate the relationship between QST and CSI and sacroiliac MRI changes.

Detailed Description

Central sensitization is hypersensitivity and increased response to normal/painless stimuli due to dysfunction in endogenous pain pathways. Quantitative sensory testing is frequently used to detect pain sensitization, and pressure pain threshold (PPT) and temporal summation (TS) are often preferred for this purpose. Recently, in addition to these methods, conditional pain modulation (CPM), in which descending pain pathways are tested, is also preferred. With PPT and TS measurement, local/generalized sensitivity increase can be detected in patients who develop pain sensitization. Observation of increased nociceptor response and decrease in pressure pain threshold in the tissue damaged area is interpreted in favor of peripheral sensitization, while obtaining a similar response in adjacent or distant areas is defined as generalized increased sensitivity. Although it is known that local hyperalgesia is one of the main findings of inflammation, studies that have shown this quantitatively are limited. Inflammatory lesions are observed in patients with axial spondyloarthritis, especially in the active stages of the disease, and the relationship of these lesions with PPT, TS and CPM values and pain sensitization is unknown. Therefore, in this study, it was planned to investigate the relationship of inflammatory and structural lesions detected by sacroiliac MRI with regional PPT,TS, CPM and pain sensitization in patients diagnosed with axSpA.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-15
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-21
• Last Update Submitted: 2021-08-21
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosed with axSpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria
• Aged between 18-65 years

Exclusion Criteria

• Had an other rheumatic diseases, peripheral vascular disease, peripheral neuropathy and spine disease (e.g., symptomatic herniated disc, spinal stenosis),
• Using centrally acting pain medications (e.g., pregabaline, duloxetine, opioids) or glucocorticoids (>10 mg prednisone or its equivalent) within 3 months of study enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Central Sensitization Inventory	Patients with Axial SpondyloArthritis
Patients	Spondyloarthritis Research Consortium of Canada scoring system	Patients with Axial SpondyloArthritis
Patients	Temporal Summation	Patients with Axial SpondyloArthritis
Patients	Pressure pain threshold	Patients with Axial SpondyloArthritis
Patients	Conditioned pain modulation	Patients with Axial SpondyloArthritis

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory (CSI)	1 months	25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points. As the score increases, the severity of sensitization is considered to increase.
Temporal summation (TS)	1 months	TS will be evaluated over the trapezius muscle and sacroiliac joints with manuel algometer. 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. As the score increases, the severity of sensitization is considered to increase.
Conditioned pain modulation (CPM)	1 months	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 7 Celsius 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. Higher scores indicate better descending pain inhibition.
Pressure pain threshold (PPT)	1 months	The sacroiliac PPT scores were obtained from four measurement points; the first point was located 1 cm medially and caudally from spina iliaca posterior superior (SIPS) and 3 more laterally, medially, and cranially. Lower scores are interpreted in favor of increased pain sensitization.

Secondary Outcome Measures

Name	Time	Method
Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system	1 months	SPARCC scoring consists of two subcomponents to detect sacroiliitis activation and structural damage.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey