NCT04776707

Brief Summary

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system. Patient history and physical examination, quantitative sensory testing(QST), imaging methods, neuroinflammatory marker levels, electrodiagnostic studies and clinical scales can be used in the diagnosis of CS, but there is no standardized method yet. Among these methods, clinical scales are preferred because they are practical, inexpensive and do not require experience. The Sensory Hypersensitivity Scale was developed by Dixon et al. for investigate the personal hypersensitivity and CS. The aim of this study is to investigate the Turkish validity and reliability of the sensory hypersensitivity scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 19, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 17, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

February 19, 2021

Last Update Submit

August 15, 2021

Conditions

Central SensitisationHypersensitivity

Keywords

central sensitizationchronic painsensory hypersensitivitySensory hypersensitivity scaleCentral sensitization inventory

Outcome Measures

Primary Outcomes (3)

  • Sensory hypersensitivity scale

    Standardized questionnaire to detective sensor hypersensitivity. This scale includes 25 questions in the form of a Likert scale and questions the increase in modality-specific (touch, taste, hearing, etc.) sensitivity as well as the general sensitivity increase. It is accepted that the higher the score, the higher the sensory hypersensitivity.

    6 months

  • Central sensitization inventory

    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.

    6 months

  • Hospital Anxiety and Depression Scale (HADS)

    This scale included the 14 item checklist in which 7 items relate to anxiety. A subscore of \> 8 for depression or anxiety would indicate a clinical case.

    6 months

Secondary Outcomes (1)

  • VAS pain

    6 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients aged 18-75 years diagnosed with chronic musculoskeletal disorders will be recruited from a PMR outpatient clinic of a state hospital

You may qualify if:

  • Have musculoskeletal pain that lasts for at least 3 months
  • Accepting to participate in the study

You may not qualify if:

  • Refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feyza Nur YUCEL

Sinop, Boyabat, 57200, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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

  • 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

  • Dixon EA, Benham G, Sturgeon JA, Mackey S, Johnson KA, Younger J. Development of the Sensory Hypersensitivity Scale (SHS): a self-report tool for assessing sensitivity to sensory stimuli. J Behav Med. 2016 Jun;39(3):537-50. doi: 10.1007/s10865-016-9720-3. Epub 2016 Feb 12.

    PMID: 26873609BACKGROUND

  • Maguire M. The psychopharmacology of epilepsy. Handb Clin Neurol. 2019;165:207-227. doi: 10.1016/B978-0-444-64012-3.00012-5.

    PMID: 31727213BACKGROUND

MeSH Terms

Conditions

HypersensitivityChronic Pain

Condition Hierarchy (Ancestors)

Immune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Canan ŞANAL TOPRAK, Asst.Prof

    Marmara University

    STUDY CHAIR

Central Study Contacts

Feyza N YUCEL, specialist

CONTACT

05385577059dr.fny28@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

March 2, 2021

Study Start

August 16, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

August 17, 2021

Record last verified: 2021-01

Locations

TU(1)