Correlation Between Central Sensitization Inventory and Posturographic Data

Central Nervous System Sensitization Clinical Trial

Official title:

Correlation Between Central Sensitization Inventory and Posturographic Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058003
• Other study ID #: CI-IRB-20170124001
• Status: Completed
• Start date: May 2016
• Est. completion date: April 2021

Study information

• Verified date: August 2021
• Source: Caps Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2021
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Sensitization

Intervention

Diagnostic Test:
• 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:
• 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)

Locations

Country	Name	City	State
Australia	Small Street Clinic	Hampton	Victoria
United States	Innova Brain Rehabilitation	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Caps Research Network

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately after data collection
Primary	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	immediately after data collection
Secondary	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	immediately after data collection