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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03058003




Registration number
NCT03058003
Ethics application status
Date submitted
16/02/2017
Date registered
20/02/2017
Date last updated
16/07/2020

Titles & IDs
Public title
Correlation Between Central Sensitization Inventory and Posturographic Data
Scientific title
Correlation Between Central Sensitization Inventory and Posturographic Data
Secondary ID [1] 0 0
CI-IRB-20170124001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Sensitization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Posturography Evaluation
Other interventions - Central Sensitization Inventory

Patients - subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory

Healthy - subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory


Diagnosis / Prognosis: Posturography Evaluation
Posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended

Other interventions: Central Sensitization Inventory
Standard chronic pain questionnaire: the subjects will be required to score each of the 25 items on a scale from 0 (never) to 4 (always)

Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stability Score - The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Timepoint [1] 0 0
immediately after data collection
Primary outcome [2] 0 0
CSI - The sum of all the answers to the Central Sensitization Inventory will be used to investigate if there is any difference between healthy controls and subjects affected by chronic pain. Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
Timepoint [2] 0 0
immediately after data collection
Secondary outcome [1] 0 0
CSI-SS - Correlation between the Stability Score and the CSI result for each individual to determine if balance is an indicator of Central Nervous System Sensitization
Timepoint [1] 0 0
immediately after data collection

Eligibility
Key inclusion criteria
- Adults, self assessed to be in good health, or medically diagnosed with any of the
following pathologies: Chronic nonspecific low back pain (CNSLBP), Fibromyalgia (FM),
Cervicogenic Headche (CH), Chronic Tension Type Headache (CTT), Irritable Bowel
Syndrome (IBS), Whiplash Associated Disorder (WAD), Temporomandibular Disorder (TMD)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant women will be excluded, as will be minors

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Small Street Clinic - Hampton
Recruitment postcode(s) [1] 0 0
3188 - Hampton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Other
Name
Caps Research Network
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the use of balance as a screening tool for Central Sensitization, a condition
of the nervous system that is associated with the development and maintenance of chronic
pain. This is done by comparing the scores of a gold standard screening tool (the Central
Sensitization Inventory) with balance data.
Trial website
https://clinicaltrials.gov/show/NCT03058003
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Noone, PhD
Address 0 0
Caps Research Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications