NCT05495594

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 8, 2022

Last Update Submit

August 22, 2022

Conditions

Keywords

Central Sensitisationmedical studentsCentral Sensitisation inventory

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Medical students aged between 18-25 years old

You may qualify if:

  • Being between the ages of 18-25
  • Being a medical student

You may not qualify if:

  • neurological disease
  • rheumatic disease
  • uncontrolled hypothyroidism
  • hyperparathyroidism
  • diabetes mellitus
  • infectious diseas
  • malignancy
  • not signing the voluntary consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey

Izmir, Turkey (Türkiye)

Location

Related Publications (9)

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

    PMID: 23490634BACKGROUND
  • Yunus M. Central sensitivity syndromes: a unified concept for fibromyalgia and other similar maladies. J Indian Rheum Assoc 2000;8(1):27-33

    BACKGROUND
  • 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.

    PMID: 21951710BACKGROUND
  • 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.

    PMID: 35382371BACKGROUND
  • 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.

    PMID: 21349445BACKGROUND
  • 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.

    PMID: 17350675BACKGROUND
  • 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.

    PMID: 3272296BACKGROUND
  • 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.

    PMID: 11346323BACKGROUND
  • 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.

    PMID: 10403267BACKGROUND

Study Officials

  • Elif Akalın, MD,Prof

    Medical Faculty of Dokuz Eylül University, İzmir, Turkey

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor,MD

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

April 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 1, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations