- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776707
Reliability and Validity of the Turkish Version of Sensory Hypersensivity Scale
August 15, 2021 updated by: Marmara University
Investigation of the Validity and Reliability of the Turkish Translation of the Sensory Hypersensitivity Scale
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
The term central sensitization (CS) was first used by Wolf in 1988 and was explained as the increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system.
With the development of CS, a decrease in the pain threshold and an increase in generalized sensitivity occur.
There is no method for the diagnosis of CS is accepted as a gold standard.
Clinical scales and quantitative sensory testing (QST) is used for this purpose widely.
In addition, the well-known scale used for the evaluation of CS is the Central Sensitization Inventory (CSI), developed for detect CS in chronic pain patients.
The use of CSI, which is more practical to use, is becoming widespread because QST takes time, is costly and requires experienced practitioners.
Considering the place of sensory hypersensitivity in the diagnosis of CS and the application difficulties of QST, the Sensory Hypersensitivity Scale was developed in 2016.
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.
Especially in chronic pain conditions, there is an increase in the evidence regarding the development of CS day by day, and the need for auxiliary tools in diagnosis is increasing in parallel.
In this study, it was planned to show the Turkish reliability and validity the Sensory Hypersensitivity Scale.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feyza N YUCEL, specialist
- Phone Number: 05385577059
- Email: dr.fny28@gmail.com
Study Locations
-
-
Boyabat
-
Sinop, Boyabat, Turkey, 57200
- Recruiting
- Feyza Nur YUCEL
-
Contact:
- Feyza N YUCEL
- Phone Number: 05385577059
- Email: dr.fny28@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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
Description
Inclusion Criteria:
- Have musculoskeletal pain that lasts for at least 3 months
- Accepting to participate in the study
Exclusion Criteria:
- Refuse to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory hypersensitivity scale
Time Frame: 6 months
|
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
Time Frame: 6 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.
|
6 months
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS pain
Time Frame: 6 months
|
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)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Canan Şanal Toprak, Asst.Prof, Marmara University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Maguire M. The psychopharmacology of epilepsy. Handb Clin Neurol. 2019;165:207-227. doi: 10.1016/B978-0-444-64012-3.00012-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 16, 2021
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
February 19, 2021
First Submitted That Met QC Criteria
February 28, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 15, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2021.115
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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