Correlation Between Central Sensitization Inventory and Posturographic Data

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Sensitization
• Intervention / Treatment: Diagnostic test: Posturography Evaluation; Other: Central Sensitization Inventory

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 Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Hampton, Victoria, Australia, 3188
      • Small Street Clinic
• United States
  • Georgia
    • Marietta, Georgia, United States, 30062
      • Innova Brain Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults, self assess to be in good health or diagnosed with Central Nervous System Sensitization

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory	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 Names: Balance Testing; CAPS® Testing; 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)
Healthy; subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory	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 Names: Balance Testing; CAPS® Testing; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Caps Research Network
• Investigators: Principal Investigator: Paul Noone, PhD, Caps Research Network

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: chronic pain; Fibromyalgia; Temporomandibular disorder; Irritable bowel syndrome; balance, postural; postural equilibrium; Cervicogenic headache; Chronic nonspecific low back pain; Whiplash associated disorder; Chronic tension type headache
• Other Study ID Numbers: CI-IRB-20170124001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No