- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485078
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
Study Overview
Status
Conditions
Intervention / Treatment
- Diagnostic test: Central Sensitization Inventory
- Other: Pittsburgh Sleep Quality Index
- Other: Visual analogue scale
- Diagnostic test: Pressure pain threshold
- Diagnostic test: Temporal summation
- Diagnostic test: Conditioned pain modulation
- 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: Fibromyalgia Rapid Screening Tool
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34100
- Feyza Nur YUCEL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
The exclusion criteria of the control grup were same as that of the patients.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Axial spondyloarthritis patients
QST with clinical scales
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Standardized questionnaire to determine the level of central sensitization
Other Names:
Standardized questionnaire to investigate the sleep quality and disturbance
Other Names:
global pain score on a 0 to 10
Other Names:
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.
Other Names:
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.
Other Names:
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
Other Names:
Standardized questionnaire to determine the level of disease activity in AxSpa patients
Other Names:
Standardized questionnaire to investigate the quality of life in AxSpa patients
Other Names:
Standardized questionnaire to investigate the disability
Other Names:
Standardized questionnaire to investigate the depression
Other Names:
Standardized questionnaire to investigate the fatigue
Other Names:
Standardized questionnaire to detect fibromyalgia
Other Names:
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Healthy controls
QST
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Sensitization Inventory (CSI)
Time Frame: 3 months
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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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold
Time Frame: 3 months
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The spinal hyperalgesia will be evaluated from C3 and C7 (cervical); T6 and T2 (thoracic); L3 and L5 (lumbar) levels.
The PPT assessments of these levels were performed over the spinous process and 2 cm right and left side of the corresponding spinous process.
The sacroiliac PPT scores were obtained from four measurement points [1].
Trapezius muscle will be used to evaluate distant control point
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3 months
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Temporal summation
Time Frame: 3 months
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TS scores will be evaluated over the trapezius muscle, sacroiliac joints, C7, T6, and L3 spine.
TS scores will be calculated for each spine 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 ve asked to rate their pain using 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
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3 months
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Conditioned pain modulation
Time Frame: 3 months
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For the assessment of 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.
After that the right hand of the patient will be immersed in 7 degrees Celcius water for 20 seconds to create a conditioning stimulus.
Second stimulus with the same intensity of first one was applied to trapezius after the conditioning stimulus and patients asked to rate their pain.
The ratio between the first and second VAS values will be defined as CPM
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3 months
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VAS pain
Time Frame: 3 months
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The patients pain severity will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
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3 months
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 3 months
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BASDAI is one of the most frequently used scales for determining disease activity in axSpA patients and includes questions to evaluate the patient's axial and peripheral symptoms, fatigue and morning stiffness.
The questionnaire consists of 10 questions in total and is interpreted in favor of disease activity of 4 points or more.
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3 months
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Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Time Frame: 3 months
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This scale was developed by Doward et.al in 2003 and consists of 18 questions in total.
Each question is answered as yes or no, and the total score is calculated by evaluating the yes answer as 1 and no as 0. It is frequently used in clinical practice because it helps to evaluate the effects of the disease and determine treatment strategies in patients diagnosed with AxSpa.
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3 months
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Istanbul Low Back Pain Disability Index (ILBPDI)
Time Frame: 3 months
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This scale was developed for assessing the severity of disability in chronic low back pain patients by Duruöz et.al in 2013.
This scale consists of 18 questions in the form of a Likert scale that evaluates the limitation of daily life activities of patients in the last month.
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3 months
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Beck Depression Inventory (BDI)
Time Frame: 3 months
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This questionnaire consists of 21 questions, each with four options.
Scoring is interpreted as 0-9 normal, 10-18 mild depression, 19-29 moderate depression and 30-63 points as severe depression.
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3 months
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Fatigue severity scale (FSS)
Time Frame: 3 months
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The FSS includes 9 questions included in order to determine the negative effects of fatigue intensity and fatigue on daily life activities in the last week.
İf the score more than 6.1, this is interpreted in favor of chronic fatigue syndrome.
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3 months
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 3 months
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This scale is designed for quantitative measurement of sleep quality and consists of 24 questions in total.
The questions are divided into 7 sections those included sleep disturbance-related symptoms.
High scores are associated with poor sleep quality.
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3 months
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Fibromyalgia Rapid Screening Tool
Time Frame: 3 months
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This questionnaire is consisted of 6 questions in which fibromyalgia-related clinical parameters are investigated.
The patient scoring at least 5 points is considered has fibromyalgia.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mehmet T DURUOZ, Professor, Marmara University
Publications and helpful links
General Publications
- 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.
- Strand V, Singh JA. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct;23(7):383-391. doi: 10.1097/RHU.0000000000000589.
- 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. Erratum In: Pain. 2006 Nov;125(1-2):197.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2019.695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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