Axial SpondyloarthritisNCT04485078
Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
An observational study of Axial Spondyloarthritis and Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Central Sensitisation
- What is being tested?
- Pressure pain threshold, Temporal summation and Conditioned pain modulation
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2019to 18 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Diagnosed with axSpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria Aged between 18-65 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and the Functional Impact of Central Sensitization On Patients With Axial Spondyloarthritis
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.
Read the 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
- Axial Spondyloarthritis, Central Sensitisation
- Being tested
- Pressure pain threshold, Temporal summation, Conditioned pain modulation, Central Sensitization Inventory, Bath Ankylosing Spondylitis Disease Activity Index
- Keywords
- Axial spondyloarthritis, central sensitization, quantitative sensory testing, central sensitization inventory
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure pain thresholdDiagnostic test
Also called PPT
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.
Temporal summationDiagnostic test
Also called TS
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.
Conditioned pain modulationDiagnostic test
Also called 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 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
Central Sensitization InventoryDiagnostic test
Also called CSI
Standardized questionnaire to determine the level of central sensitization
Bath Ankylosing Spondylitis Disease Activity IndexOther
Also called BASDAI
Standardized questionnaire to determine the level of disease activity in AxSpa patients
Ankylosing Spondylitis Quality of LifeOther
Also called ASQoL
Standardized questionnaire to investigate the quality of life in AxSpa patients
Istanbul Low Back Pain Disability IndexOther
Also called ILPBDI
Standardized questionnaire to investigate the disability
Beck Depression InventoryOther
Also called BDI
Standardized questionnaire to investigate the depression
Fatigue Severity ScaleOther
Also called FSS
Standardized questionnaire to investigate the fatigue
Pittsburgh Sleep Quality IndexOther
Also called PSQI
Standardized questionnaire to investigate the sleep quality and disturbance
Fibromyalgia Rapid Screening ToolOther
Also called FIRST
Standardized questionnaire to detect fibromyalgia
Visual analogue scaleOther
Also called VAS
global pain score on a 0 to 10
| Study group | Role | What they receive |
|---|---|---|
| Axial spondyloarthritis patients | QST with clinical scales Receives: 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 Receives: Diagnostic Test: Pressure pain threshold; Diagnostic Test: Temporal summation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
Pressure pain threshold
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
Measured: 3 months
Temporal summation
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
Measured: 3 months
Conditioned pain modulation
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
Measured: 3 months
VAS pain
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)
Measured: 3 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Measured: 3 months
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
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.
Measured: 3 months
Istanbul Low Back Pain Disability Index (ILBPDI)
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.
Measured: 3 months
Beck Depression Inventory (BDI)
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.
Measured: 3 months
Fatigue severity scale (FSS)
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.
Measured: 3 months
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 3 months
Fibromyalgia Rapid Screening Tool
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Oct 2019
- Primary completion14 Feb 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet T DURUOZ, Professor, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485078
- Sponsor's protocol ID
- 09.2019.695
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Strand V, Singh JA. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct;23(7):383-391. doi: 10.1097/RHU.0000000000000589.
PubMed 28937474Rolke 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.
PubMed 16697110Arendt-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.
PubMed 9324089Yarnitsky 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.
PubMed 25330039Neblett 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.
PubMed 23490634Doward 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.
PubMed 12480664Duruoz 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.
PubMed 23411648van 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.
PubMed 27008288Middlebrook 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.
PubMed 32469913
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and the Functional Impact of Central Sensitization On Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT04485078
- Acronym / sponsor ID
- 09.2019.695
- Conditions
- Axial Spondyloarthritis, Central Sensitisation
- Keywords
- Axial spondyloarthritis, central sensitization, quantitative sensory testing, central sensitization inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial spondyloarthritis patients | – | 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 scaleQST with clinical scales |
| Healthy controls | – | Diagnostic Test: Pressure pain threshold, Diagnostic Test: Temporal summationQST |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Diagnosed with axSpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria Aged between 18-65 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure pain thresholdAlso: PPTThe 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 | Axial spondyloarthritis patients, Healthy controls |
| Temporal summationAlso: TSTS 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 | Axial spondyloarthritis patients, Healthy controls |
| Conditioned pain modulationAlso: CPMFirst 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 | Axial spondyloarthritis patients |
| Central Sensitization InventoryAlso: CSIStandardized questionnaire to determine the level of central sensitization | Diagnostic test | Axial spondyloarthritis patients |
| Bath Ankylosing Spondylitis Disease Activity IndexAlso: BASDAIStandardized questionnaire to determine the level of disease activity in AxSpa patients | Other | Axial spondyloarthritis patients |
| Ankylosing Spondylitis Quality of LifeAlso: ASQoLStandardized questionnaire to investigate the quality of life in AxSpa patients | Other | Axial spondyloarthritis patients |
| Istanbul Low Back Pain Disability IndexAlso: ILPBDIStandardized questionnaire to investigate the disability | Other | Axial spondyloarthritis patients |
| Beck Depression InventoryAlso: BDIStandardized questionnaire to investigate the depression | Other | Axial spondyloarthritis patients |
| Fatigue Severity ScaleAlso: FSSStandardized questionnaire to investigate the fatigue | Other | Axial spondyloarthritis patients |
| Pittsburgh Sleep Quality IndexAlso: PSQIStandardized questionnaire to investigate the sleep quality and disturbance | Other | Axial spondyloarthritis patients |
| Fibromyalgia Rapid Screening ToolAlso: FIRSTStandardized questionnaire to detect fibromyalgia | Other | Axial spondyloarthritis patients |
| Visual analogue scaleAlso: VASglobal pain score on a 0 to 10 | Other | Axial spondyloarthritis patients |
Primary outcome
Central Sensitization Inventory (CSI)
Time frame: 3 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.
11 secondary outcomes
Pressure pain threshold
Time frame: 3 months
Temporal summation
Time frame: 3 months
Conditioned pain modulation
Time frame: 3 months
VAS pain
Time frame: 3 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 3 months
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Time frame: 3 months
Istanbul Low Back Pain Disability Index (ILBPDI)
Time frame: 3 months
Beck Depression Inventory (BDI)
Time frame: 3 months
Fatigue severity scale (FSS)
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
Fibromyalgia Rapid Screening Tool
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Results publication: PubMed 28937474Strand V, Singh JA. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct;23(7):383-391. doi: 10.1097/RHU.0000000000000589.
- Results publication: PubMed 16697110Rolke 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.
- Results publication: PubMed 9324089Arendt-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.
- Results publication: PubMed 25330039Yarnitsky 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.
- Results publication: PubMed 23490634Neblett 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.
- Results publication: PubMed 12480664Doward 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.
- Results publication: PubMed 23411648Duruoz 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.
- Results publication: PubMed 27008288van 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.
- Results publication: PubMed 32469913Middlebrook 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet T DURUOZ, Professor study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis and Central Sensitisation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485078, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.