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Clinical Trials/NCT03058003
NCT03058003
Completed
Not Applicable

Correlation Between Central Sensitization Inventory and Posturographic Data

Caps Research Network2 sites in 2 countries180 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Sensitization
Sponsor
Caps Research Network
Enrollment
180
Locations
2
Primary Endpoint
CSI
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

First, subjects will be asked to answer a brief medical questionnaire pertaining their general health status: since some of the subjects will be self-assessed to be "healthy" (no medical examination will be conducted to determine if this is indeed the case), the questionnaire will be used to determine if there are any possible known causes of poor balance performance. The questionnaire will not constitute an inclusion/exclusion criterion, it just has a classification purpose. Subjects will then be asked to fill in the Central Sensitization Inventory (CSI), scoring each of the 25 items on a scale from 0 (never) to 4 (always). Then, subjects will stand for 2 minutes on a compliant surface (a 4" tall foam cushion of known mechanical properties) to "learn" how to stand on it. Afterward, they will undergo 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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
April 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Caps Research Network
Responsible Party
Sponsor

Eligibility Criteria

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)

Exclusion Criteria

  • Pregnant women will be excluded, as will be minors

Outcomes

Primary Outcomes

CSI

Time Frame: immediately after data collection

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

Stability Score

Time Frame: immediately after data collection

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

Secondary Outcomes

  • CSI-SS(immediately after data collection)

Study Sites (2)

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