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

NCT04485078 | Completed

• 1 other identifier: 09.2019.695
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 et.al 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.

Conditions

Axial Spondyloarthritis; Central Sensitisation

Keywords

Axial spondyloarthritis; central sensitization; quantitative sensory testing; central sensitization inventory

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (11)

• Pressure pain threshold

  3 months

• Temporal summation

  3 months

• Conditioned pain modulation

  3 months

• VAS pain

  3 months

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  3 months

Study Arms (2)

Axial spondyloarthritis patients

QST with clinical scales

Diagnostic Test: Pressure pain threshold; Diagnostic Test: Temporal summation; Diagnostic Test: Conditioned pain modulation; Diagnostic Test: Central Sensitization Inventory; Other: Bath Ankylosing Spondylitis Disease Activity Index; Other: Ankylosing Spondylitis Quality of Life; Other: Istanbul Low Back Pain Disability Index; Other: Beck Depression Inventory; Other: Fatigue Severity Scale; Other: Pittsburgh Sleep Quality Index; Other: Fibromyalgia Rapid Screening Tool; Other: Visual analogue scale

Healthy controls

QST

Diagnostic Test: Pressure pain threshold; Diagnostic Test: Temporal summation

Interventions

Pressure pain threshold DIAGNOSTIC_TEST

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.

Also known as: PPT

Axial spondyloarthritis patients; Healthy controls

Temporal summation DIAGNOSTIC_TEST

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.

Also known as: TS

Axial spondyloarthritis patients; Healthy controls

Conditioned pain modulation DIAGNOSTIC_TEST

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

Also known as: CPM

Axial spondyloarthritis patients

Central Sensitization Inventory DIAGNOSTIC_TEST

Standardized questionnaire to determine the level of central sensitization

Also known as: CSI

Axial spondyloarthritis patients

Bath Ankylosing Spondylitis Disease Activity Index OTHER

Standardized questionnaire to determine the level of disease activity in AxSpa patients

Also known as: BASDAI

Axial spondyloarthritis patients

Ankylosing Spondylitis Quality of Life OTHER

Standardized questionnaire to investigate the quality of life in AxSpa patients

Also known as: ASQoL

Axial spondyloarthritis patients

Istanbul Low Back Pain Disability Index OTHER

Standardized questionnaire to investigate the disability

Also known as: ILPBDI

Axial spondyloarthritis patients

Beck Depression Inventory OTHER

Standardized questionnaire to investigate the depression

Also known as: BDI

Axial spondyloarthritis patients

Fatigue Severity Scale OTHER

Standardized questionnaire to investigate the fatigue

Also known as: FSS

Axial spondyloarthritis patients

Pittsburgh Sleep Quality Index OTHER

Standardized questionnaire to investigate the sleep quality and disturbance

Also known as: PSQI

Axial spondyloarthritis patients

Fibromyalgia Rapid Screening Tool OTHER

Standardized questionnaire to detect fibromyalgia

Also known as: FIRST

Axial spondyloarthritis patients

Visual analogue scale OTHER

global pain score on a 0 to 10

Also known as: VAS

Axial spondyloarthritis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients aged 18-65 years diagnosed with axSpA according to the ASAS criteria will be recruited from a Rheumatology outpatient clinic of a single tertiary care hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Feyza Nur YUCEL

Istanbul, 34100, Turkey (Türkiye)

Location

Related Publications (9)

• Strand V, Singh JA. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct;23(7):383-391. doi: 10.1097/RHU.0000000000000589.

  PMID: 28937474 RESULT

• Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.

  PMID: 16697110 RESULT

• Arendt-Nielsen L, Graven-Nielsen T, Svensson P, Jensen TS. Temporal summation in muscles and referred pain areas: an experimental human study. Muscle Nerve. 1997 Oct;20(10):1311-3. doi: 10.1002/(sici)1097-4598(199710)20:103.0.co;2-5.

  PMID: 9324089 RESULT

• Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.

  PMID: 25330039 RESULT

• Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.

  PMID: 23490634 RESULT

• Doward LC, Spoorenberg A, Cook SA, Whalley D, Helliwell PS, Kay LJ, McKenna SP, Tennant A, van der Heijde D, Chamberlain MA. Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis. 2003 Jan;62(1):20-6. doi: 10.1136/ard.62.1.20.

  PMID: 12480664 RESULT

• Duruoz MT, Ozcan E, Ketenci A, Karan A. Development and validation of a functional disability index for chronic low back pain. J Back Musculoskelet Rehabil. 2013;26(1):45-54. doi: 10.3233/BMR-2012-00349.

  PMID: 23411648 RESULT

• 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.

  PMID: 27008288 RESULT

• Middlebrook N, Heneghan NR, Evans DW, Rushton A, Falla D. Reliability of temporal summation, thermal and pressure pain thresholds in a healthy cohort and musculoskeletal trauma population. PLoS One. 2020 May 29;15(5):e0233521. doi: 10.1371/journal.pone.0233521. eCollection 2020.

  PMID: 32469913 RESULT

Related Links

• IASP terminology

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mehmet T DURUOZ, Professor

  Marmara University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: October 20, 2019
• Primary Completion: February 14, 2020
• Study Completion: April 18, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-07

Locations

TU (1)