Correlation Between Central Sensitization Inventory and Posturographic Data

NCT ID: NCT03058003

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-04-30

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.

Conditions

Central Nervous System Sensitization

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

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

Posturography Evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Central Sensitization Inventory

Intervention Type: OTHER

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

Posturography Evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Central Sensitization Inventory

Intervention Type: OTHER

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)

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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 Type: OTHER

Other Intervention Names

Balance Testing; CAPS® Testing

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caps Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Noone, PhD

Role: PRINCIPAL_INVESTIGATOR

Caps Research Network

Locations

Innova Brain Rehabilitation

Marietta, Georgia, United States

Small Street Clinic

Hampton, Victoria, Australia

Countries

United States; Australia

Other Identifiers

CI-IRB-20170124001

Identifier Type: -

Identifier Source: org_study_id