Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
324 participants
OBSERVATIONAL
2022-04-01
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation
NCT06269068
Sensorial Discrimination in Chronic Low Back Pain
NCT05169918
Kinesiophobia in Patients With Chronic Low Back Pain
NCT06190041
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain
NCT05937503
Chronic Neck Pain and Central Sensizitation
NCT06976398
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being a medical student
Exclusion Criteria
* rheumatic disease
* uncontrolled hypothyroidism
* hyperparathyroidism
* diabetes mellitus
* infectious diseas
* malignancy
* not signing the voluntary consent form
18 Years
25 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dokuz Eylul University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nihan ERDINC GUNDUZ
assistant professor,MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elif Akalın, MD,Prof
Role: STUDY_DIRECTOR
Medical Faculty of Dokuz Eylül University, İzmir, Turkey
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
Izmir, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Yunus 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.
Duzce 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.
Kindler 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.
Yunus 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.
Woolf 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.
Aaron 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.
McBeth 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TıpFakogrencisantralsensitzsyn
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.