Correlation Between Central Sensitization Inventory and Posturographic Data

Completed

• Conditions: Central Nervous System Sensitization
• Interventions: Diagnostic Test: Posturography Evaluation; Other: Central Sensitization Inventory

• Registration Number: NCT03058003
• Lead Sponsor: Caps Research Network

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-20
• Primary Completion: 2018-01
• Study Completion: 2021-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Posturography Evaluation	subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory
Healthy	Central Sensitization Inventory	subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory
Patients	Central Sensitization Inventory	subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory
Patients	Posturography Evaluation	subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory

Primary Outcome Measures

Name	Time	Method
CSI	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	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 Outcome Measures

Name	Time	Method
CSI-SS	immediately after data collection	Correlation between the Stability Score and the CSI result for each individual to determine if balance is an indicator of Central Nervous System Sensitization

Trial Locations

Locations (2)

Small Street Clinic; 🇦🇺 Hampton, Victoria, Australia

Innova Brain Rehabilitation; 🇺🇸 Marietta, Georgia, United States