Central SensitisationNCT05495594
Central Sensitization in Medical Students
An observational study of Central Sensitisation, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Central sensitization (SS); is a physiological phenomenon caused by neuronal dysregulation and hyperexcitability in the central nervous system, resulting in hypersensitivity to painful and painless stimuli.Central sensitization syndromes (CSS); defines disorders in which SS originates and cannot be medically explained… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Central Sensitisation
- How many people
- 324 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Jul 2022
- 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 25 years
- All sexes
- Adult
Study population: Medical students aged between 18-25 years old
Who may be able to join
- Being between the ages of 18-25
- Being a medical student
Who cannot join
- neurological disease
- rheumatic disease
- uncontrolled hypothyroidism
- hyperparathyroidism
- diabetes mellitus
- infectious diseas
- malignancy
- not signing the voluntary consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
Izmir
About this study
Official title: Central Sensitization and Releated Factors in Medical Students: a Cross-Sectional Study
Central sensitization (SS); is a physiological phenomenon caused by neuronal dysregulation and hyperexcitability in the central nervous system, resulting in hypersensitivity to painful and painless stimuli.Central sensitization syndromes (CSS); defines disorders in which SS originates and cannot be medically explained by any organic cause. CSS include clinical conditions such as fibromyalgia syndrome (FMS), chronic fatigue syndrome (CFS), temporomandibular joint disorders (TMD), migraine/tension type headache, irritable bowel syndrome (IBS), restless legs syndrome (RLS). These disorders have many common clinical features such as pain, fatigue, sleep disturbance, increased sensitivity to painful and painless stimuli, coexistence, paresthesia, psychosocial disorders, and show the presence of SS.
The Central Sensitization Inventory (SSI) is a short, easy-to-apply scale consisting of 25 questions that identifies key symptoms in patients with SS and quantifies the degree of these symptoms. The Turkish adaptation and validity-reliability study of the SSE was conducted in 2021.
Read more
In this descriptive, cross-sectional study, it was planned to investigate the presence of central sensitization and related factors in medical faculty students.
In the 2021-2022 academic year of Dokuz Eylul University Faculty of Medicine, a total of 324 students, the number determined as a result of power analysis, will be asked to fill in a short form in which the factors related to the "Central Sensitization Inventory" and demographic data are questioned. Then, statistical analysis will be applied with the analyzed data.In addition, Central Sensitization Inventory scores of students in each term will be compared with each other.
Read the detailed description
Central sensitization (SS); It is a physiological phenomenon caused by neuronal dysregulation and hyperexcitability in the central nervous system, resulting in hypersensitivity to painful and painless stimuli. It is characterized by abnormal pain increase due to neuronal hyperreactivity and dysfunction of the descending and ascending pathways. The hypersensitivity state of the central nervous system develops due to the amplification of neuronal signals with various synaptic and neurotransmitter activities, regardless of defined peripheral inputs.
It was first described by Woolf in 1983 based on studies showing that spinal neuron hyperexcitability can be induced by peripheral tissue damage in rats. Central sensitization syndromes (CSS); it defines disorders in which SS originates and cannot be medically explained by any organic cause. CNS include clinical conditions such as fibromyalgia syndrome (FMS), chronic fatigue syndrome (CFS), temporomandibular joint disorders (TMD), migraine/tension type headache, irritable bowel syndrome (IBS), restless legs syndrome (RLS). These disorders have many common clinical features such as pain, fatigue, sleep disturbance, increased sensitivity to painful and painless stimuli, co-occurrence, paresthesia, psychosocial disorders, and show the presence of SS.
Other factors that may or may not be associated with SS; genetics, excessive sympathetic activity, endocrine dysfunction (e.g. hypofunction of the adrenal cortex and decreased growth hormone), poor sleep quality, viral infection, peripheral nociceptive sources (e.g. arthritis), environmental stimuli (air, light, noise, etc.), childhood bad experiences and psychosocial disorders.
The Central Sensitization Inventory (SSI) is a short, easy-to-apply scale consisting of 25 questions that identifies key symptoms in those with SS and quantifies the degree of these symptoms. It was developed in 2012. It helps to distinguish between different types of chronic pain patients with different degrees of SS, and makes it easier to distinguish whether the pain is due to organic causes or central sensitization.
The SSI consists of 2 parts, part A, which evaluates the symptoms thought to be associated with SS syndromes, and part B, which quickly questions whether the patient has previously received a specific diagnosis. Part A of the SSE includes all CNS symptoms, which will help clinicians identify the CNS patient. In part A, there are 25 items that question the frequency of symptoms seen in SS syndromes and are scored between 0-100 points. Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" if experienced frequently (3 points), if experienced always, it is recorded as "always" (4 points). It is accepted that SS develops in those who score above 40 on the scale. As the patient's SSI score increases, it is thought that he has more SS-related symptoms. In addition, the B part of the scale (no scoring) is the part that includes 7 separate parts that asks whether he has received any diagnosis related to one or more CNS or related conditions.
With this scale, it is aimed to help clinicians better evaluate the symptoms thought to be associated with SS, to minimize or, if possible, prevent unnecessary diagnostic and treatment procedures. The Turkish adaptation and validity-reliability study of the SSI was conducted in 2021.
In this descriptive, cross-sectional study, it was planned to investigate the presence of central sensitization and related factors in Medical Faculty students. In the 2021-2022 academic year of Dokuz Eylul University Faculty of Medicine, a total of 324 students, the number determined as a result of power analysis, will be asked to fill in a short form in which the factors related to the "Central Sensitization Inventory" and demographic data are questioned.
Power analysis was done with Openepi program. In the Openepi program, it is planned to reach at least 324 students at a 95% confidence level, with a margin of error of 50% and 5% as the worst, for 80% power over 2038 total number of students.
Distribution was made according to classes by calculation with stratified sampling method. It is planned to include at least 59 students for Term 1, at least 51 for Term 2, at least 55 for Term 3, at least 54 for Term 4, at least 47 for Term 5, and at least 59 for Term 6
Then, statistical analysis will be applied with the analyzed data. In addition, Central Sensitization Inventory scores and releated factors of students in each term will be compared with each other.
- Conditions
- Central Sensitisation
- Keywords
- Central Sensitisation, medical students, Central Sensitisation inventory
What is being measured
The primary outcome is the main question the study is designed to answer.
The Central Sensitization Inventory
The Central Sensitization Inventory consists of 2 parts, part A and B.In part A, there are 25 items that question the frequency of symptoms seen in SS syndromes and are scored between 0-100 points. Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" if experienced frequently (3 points), if experienced always, it is recorded as "always" (4 points). It is accepted that SS develops in those who score above 40 on the scale (3). As the patient's SSI score increases, it is thought that he has more SS-related symptoms. In addition, the B part of the scale (no scoring) is the part that includes 7 separate parts that asks whether he has received any diagnosis related to one or more CNS or related conditions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
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 Central SensitisationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan ERDINC GUNDUZ, Dokuz Eylul University
- Investigators
- Elif Akalın, MD,Prof, Study director, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495594
- Sponsor's protocol ID
- TıpFakogrencisantralsensitzsyn
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23490634Yunus M. Central sensitivity syndromes: a unified concept for fibromyalgia and other similar maladies. J Indian Rheum Assoc 2000;8(1):27-33
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 27.
PubMed 21951710Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
PubMed 35382371Kindler LL, Bennett RM, Jones KD. Central sensitivity syndromes: mounting pathophysiologic evidence to link fibromyalgia with other common chronic pain disorders. Pain Manag Nurs. 2011 Mar;12(1):15-24. doi: 10.1016/j.pmn.2009.10.003. Epub 2009 Dec 2.
PubMed 21349445Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.
PubMed 17350675Woolf CJ, Thompson SW, King AE. Prolonged primary afferent induced alterations in dorsal horn neurones, an intracellular analysis in vivo and in vitro. J Physiol (Paris). 1988-1989;83(3):255-66.
PubMed 3272296Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011.
PubMed 11346323McBeth J, Macfarlane GJ, Benjamin S, Morris S, Silman AJ. The association between tender points, psychological distress, and adverse childhood experiences: a community-based study. Arthritis Rheum. 1999 Jul;42(7):1397-404. doi: 10.1002/1529-0131(199907)42:73.0.CO;2-7.
PubMed 10403267
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitization and Releated Factors in Medical Students: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05495594
- Acronym / sponsor ID
- TıpFakogrencisantralsensitzsyn
- Conditions
- Central Sensitisation
- Keywords
- Central Sensitisation, medical students, Central Sensitisation inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Aug 2022 (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.
Central sensitization (SS); is a physiological phenomenon caused by neuronal dysregulation and hyperexcitability in the central nervous system, resulting in hypersensitivity to painful and painless stimuli.Central sensitization syndromes (CSS); defines disorders in which SS originates and cannot be medically explained by any organic cause. CSS include clinical conditions such as fibromyalgia syndrome (FMS), chronic fatigue syndrome (CFS), temporomandibular joint disorders (TMD), migraine/tension type headache, irritable bowel syndrome (IBS), restless legs syndrome (RLS). These disorders have many common clinical features such as pain, fatigue, sleep disturbance, increased sensitivity to painful and painless stimuli, coexistence, paresthesia, psychosocial disorders, and show the presence of SS.
The Central Sensitization Inventory (SSI) is a short, easy-to-apply scale consisting of 25 questions that identifies key symptoms in patients with SS and quantifies the degree of these symptoms. The Turkish adaptation and validity-reliability study of the SSE was conducted in 2021.
In this descriptive, cross-sectional study, it was planned to investigate the presence of central sensitization and related factors in medical faculty students.
In the 2021-2022 academic year of Dokuz Eylul University Faculty of Medicine, a total of 324 students, the number determined as a result of power analysis, will be asked to fill in a short form in which the factors related to the "Central Sensitization Inventory" and demographic data are questioned. Then, statistical analysis will be applied with the analyzed data.In addition, Central Sensitization Inventory scores of students in each term will be compared with each other.
Detailed description
Central sensitization (SS); It is a physiological phenomenon caused by neuronal dysregulation and hyperexcitability in the central nervous system, resulting in hypersensitivity to painful and painless stimuli. It is characterized by abnormal pain increase due to neuronal hyperreactivity and dysfunction of the descending and ascending pathways. The hypersensitivity state of the central nervous system develops due to the amplification of neuronal signals with various synaptic and neurotransmitter activities, regardless of defined peripheral inputs.
It was first described by Woolf in 1983 based on studies showing that spinal neuron hyperexcitability can be induced by peripheral tissue damage in rats. Central sensitization syndromes (CSS); it defines disorders in which SS originates and cannot be medically explained by any organic cause. CNS include clinical conditions such as fibromyalgia syndrome (FMS), chronic fatigue syndrome (CFS), temporomandibular joint disorders (TMD), migraine/tension type headache, irritable bowel syndrome (IBS), restless legs syndrome (RLS). These disorders have many common clinical features such as pain, fatigue, sleep disturbance, increased sensitivity to painful and painless stimuli, co-occurrence, paresthesia, psychosocial disorders, and show the presence of SS.
Other factors that may or may not be associated with SS; genetics, excessive sympathetic activity, endocrine dysfunction (e.g. hypofunction of the adrenal cortex and decreased growth hormone), poor sleep quality, viral infection, peripheral nociceptive sources (e.g. arthritis), environmental stimuli (air, light, noise, etc.), childhood bad experiences and psychosocial disorders.
The Central Sensitization Inventory (SSI) is a short, easy-to-apply scale consisting of 25 questions that identifies key symptoms in those with SS and quantifies the degree of these symptoms. It was developed in 2012. It helps to distinguish between different types of chronic pain patients with different degrees of SS, and makes it easier to distinguish whether the pain is due to organic causes or central sensitization.
The SSI consists of 2 parts, part A, which evaluates the symptoms thought to be associated with SS syndromes, and part B, which quickly questions whether the patient has previously received a specific diagnosis. Part A of the SSE includes all CNS symptoms, which will help clinicians identify the CNS patient. In part A, there are 25 items that question the frequency of symptoms seen in SS syndromes and are scored between 0-100 points. Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" if experienced frequently (3 points), if experienced always, it is recorded as "always" (4 points). It is accepted that SS develops in those who score above 40 on the scale. As the patient's SSI score increases, it is thought that he has more SS-related symptoms. In addition, the B part of the scale (no scoring) is the part that includes 7 separate parts that asks whether he has received any diagnosis related to one or more CNS or related conditions.
With this scale, it is aimed to help clinicians better evaluate the symptoms thought to be associated with SS, to minimize or, if possible, prevent unnecessary diagnostic and treatment procedures. The Turkish adaptation and validity-reliability study of the SSI was conducted in 2021.
In this descriptive, cross-sectional study, it was planned to investigate the presence of central sensitization and related factors in Medical Faculty students. In the 2021-2022 academic year of Dokuz Eylul University Faculty of Medicine, a total of 324 students, the number determined as a result of power analysis, will be asked to fill in a short form in which the factors related to the "Central Sensitization Inventory" and demographic data are questioned.
Power analysis was done with Openepi program. In the Openepi program, it is planned to reach at least 324 students at a 95% confidence level, with a margin of error of 50% and 5% as the worst, for 80% power over 2038 total number of students.
Distribution was made according to classes by calculation with stratified sampling method. It is planned to include at least 59 students for Term 1, at least 51 for Term 2, at least 55 for Term 3, at least 54 for Term 4, at least 47 for Term 5, and at least 59 for Term 6
Then, statistical analysis will be applied with the analyzed data. In addition, Central Sensitization Inventory scores and releated factors of students in each term will be compared with each other.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Age groups
- Adult
- Study population
- Medical students aged between 18-25 years old
Key inclusion criteria (2 listed)
- Being between the ages of 18-25
- Being a medical student
Key exclusion criteria (8 listed)
- neurological disease
- rheumatic disease
- uncontrolled hypothyroidism
- hyperparathyroidism
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Central Sensitization Inventory
Time frame: baseline
The Central Sensitization Inventory consists of 2 parts, part A and B.In part A, there are 25 items that question the frequency of symptoms seen in SS syndromes and are scored between 0-100 points. Each symptom is defined as "never" (0 points) if the patient never experiences that symptom, "rarely" (1 point) if rarely, "sometimes" if sometimes (2 points), "frequently" if experienced frequently (3 points), if experienced always, it is recorded as "always" (4 points). It is accepted that SS develops in those who score above 40 on the scale (3). As the patient's SSI score increases, it is thought that he has more SS-related symptoms. In addition, the B part of the scale (no scoring) is the part that includes 7 separate parts that asks whether he has received any diagnosis related to one or more CNS or related conditions.
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 25 Aug 2022.
- Background: 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.
- BackgroundYunus M. Central sensitivity syndromes: a unified concept for fibromyalgia and other similar maladies. J Indian Rheum Assoc 2000;8(1):27-33
- Background: PubMed 21951710Mayer 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 27.
- Background: PubMed 35382371Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Background: PubMed 21349445Kindler LL, Bennett RM, Jones KD. Central sensitivity syndromes: mounting pathophysiologic evidence to link fibromyalgia with other common chronic pain disorders. Pain Manag Nurs. 2011 Mar;12(1):15-24. doi: 10.1016/j.pmn.2009.10.003. Epub 2009 Dec 2.
- Background: PubMed 17350675Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.
- Background: PubMed 3272296Woolf CJ, Thompson SW, King AE. Prolonged primary afferent induced alterations in dorsal horn neurones, an intracellular analysis in vivo and in vitro. J Physiol (Paris). 1988-1989;83(3):255-66.
- Background: PubMed 11346323Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011.
- Background: PubMed 10403267McBeth J, Macfarlane GJ, Benjamin S, Morris S, Silman AJ. The association between tender points, psychological distress, and adverse childhood experiences: a community-based study. Arthritis Rheum. 1999 Jul;42(7):1397-404. doi: 10.1002/1529-0131(199907)42:73.0.CO;2-7.
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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.
Elif Akalın, MD,Prof study director
Medical Faculty of Dokuz Eylül University, İzmir, Turkey
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 Central Sensitisation, run by Dokuz Eylul 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 2 inclusion and 8 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 25 Aug 2022. 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?
The Central Sensitization Inventory (time frame: baseline). 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 NCT05495594, 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 25 Aug 2022.