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

Inflammation Clinical Trial

Official title:

Investigation of the Relationship Between Sacroiliac Magnetic Resonance Imaging (MRI) Scores and Quantitative Sensory Testing in Patients With Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021783
• Other study ID #: 09.2021.64
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 15, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Central Sensitisation
• Inflammation
• Spondylarthritis

Intervention

Diagnostic Test:
• Pressure pain threshold
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.
• Central Sensitization Inventory
Standardized questionnaire to determine the level of central sensitization

Other:
• Spondyloarthritis Research Consortium of Canada scoring system
SPARCC scoring consists of two subcomponents to detect sacroiliitis activation and structural damage. In the short tau inversion recovery (STIR) sequence, 6 consecutive coronal sections will be examined and the signal increase will be scored as 0 = normal signal and 1 = increased signal. In this way, the maximum score can be 12 in a single coronal section. Evaluations Total maximum score of 72 in 6 consecutive coronal sections. In structural scoring, similar to sacroiliitis scoring, the SI joint is divided into four quadrants to evaluate whether there is fatty change, erosion, backfill and ankylosis. Each lesion is scored as 0=absent or 1=present. In this way, fatty change and erosion can be scored between 0-40 and backfill and ankylosis can be scored between 0-20 in 5 consecutive sections in total scoring.

Diagnostic Test:
• Temporal Summation
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.
• 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 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

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. — View Citation

de Goeij M, van Eijk LT, Vanelderen P, Wilder-Smith OH, Vissers KC, van der Hoeven JG, Kox M, Scheffer GJ, Pickkers P. Systemic inflammation decreases pain threshold in humans in vivo. PLoS One. 2013 Dec 17;8(12):e84159. doi: 10.1371/journal.pone.0084159. — View Citation

Kiltz U, Baraliakos X, Regel A, Bühring B, Braun J. Causes of pain in patients with axial spondyloarthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):102-107. Epub 2017 Sep 29. Review. — View Citation

Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, Conner-Spady B, Palsat J, Lambert RG. Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spon — View Citation

Maksymowych WP, Wichuk S, Chiowchanwisawakit P, Lambert RG, Pedersen SJ. Development and preliminary validation of the spondyloarthritis research consortium of Canada magnetic resonance imaging sacroiliac joint structural score. J Rheumatol. 2015 Jan;42(1 — View Citation

Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep — View Citation

Rolke R, Baron R, Maier C, Tölle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Bötefür IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihöfner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitativ — View Citation

van Leeuwen RJ, Szadek K, de Vet H, Zuurmond W, Perez R. Pain Pressure Threshold in the Region of the Sacroiliac Joint in Patients Diagnosed with Sacroiliac Joint Pain. Pain Physician. 2016 Mar;19(3):147-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Sensitization Inventory (CSI)	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.	1 months
Primary	Pressure pain threshold (PPT)	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.	1 months
Primary	Temporal summation (TS)	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.	1 months
Primary	Conditioned pain modulation (CPM)	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.	1 months
Secondary	Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system	SPARCC scoring consists of two subcomponents to detect sacroiliitis activation and structural damage.	1 months