Central SensitisationNCT04776707
Reliability and Validity of the Turkish Version of Sensory Hypersensivity Scale
An observational study of Central Sensitisation and Hypersensitivity, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Sensitisation, Hypersensitivity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2021to 1 May 2022
- How long will I take part?
- 15 Days
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Have musculoskeletal pain that lasts for at least 3 months
- Accepting to participate in the study
Who cannot join
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Feyza Nur YUCEL
Sinop, Boyabat, 57200
Feyza N YUCEL, 05385577059, dr.fny28@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Central Sensitisation, Hypersensitivity
- Keywords
- central sensitization, chronic pain, sensory hypersensitivity, Sensory hypersensitivity scale, Central sensitization inventory
- Medical subject headings
- Hypersensitivity, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
VAS pain
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start16 Aug 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan ŞANAL TOPRAK, Asst.Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776707
- Sponsor's protocol ID
- 09.2021.115
- Status last verified
- Jan 2021
- First submitted
- 19 Feb 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 3272296Mayer 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 21951710Dixon 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.
PubMed 26873609Maguire M. The psychopharmacology of epilepsy. Handb Clin Neurol. 2019;165:207-227. doi: 10.1016/B978-0-444-64012-3.00012-5.
PubMed 31727213
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of the Turkish Translation of the Sensory Hypersensitivity Scale
- ClinicalTrials.gov ID
- NCT04776707
- Acronym / sponsor ID
- 09.2021.115
- Conditions
- Central Sensitisation, Hypersensitivity
- Keywords
- central sensitization, chronic pain, sensory hypersensitivity, Sensory hypersensitivity scale, Central sensitization inventory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 2 Mar 2021 (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 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Have musculoskeletal pain that lasts for at least 3 months
- Accepting to participate in the study
Key exclusion criteria (1 listed)
- Refuse to participate in the study
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
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.
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.
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.
1 secondary outcome
VAS pain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- 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 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 26873609Dixon 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.
- Background: PubMed 31727213Maguire M. The psychopharmacology of epilepsy. Handb Clin Neurol. 2019;165:207-227. doi: 10.1016/B978-0-444-64012-3.00012-5.
Related trials for Central Sensitisation
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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.
Canan ŞANAL TOPRAK, Asst.Prof study chair
Marmara University
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 and Hypersensitivity, run by Marmara 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 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feyza N YUCEL, specialist (05385577059, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory hypersensitivity scale (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04776707, which also lists 4 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 17 Aug 2021.