Correlation Between Central Sensitization Inventory and Posturographic Data

NCT03058003 — Completed, 180 participants, Caps Research Network

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RegistryNCT03058003
StatusCompleted
Study typeObservational
Enrollment180 (Actual)
SponsorCaps Research Network (Other)
ConditionsCentral Nervous System Sensitization
InterventionsPosturography Evaluation, Central Sensitization Inventory (Diagnostic test, other)
Datesstart 2016-05-01, primary completion 2018-01-01, completion 2021-04-01, first posted 2017-02-20, last updated 2021-08-04
Locations2 sites in United States, Australia

Related Papers Related Patents Related Grants Related Experts
All trials for Central Nervous System Sensitization All trials of Posturography Evaluation All trials of Central Sensitization Inventory

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PatientsDiagnostic Test: Posturography Evaluation; Other: Central Sensitization Inventorysubjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory
HealthyDiagnostic Test: Posturography Evaluation; Other: Central Sensitization Inventorysubjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory
  • Posturography Evaluation (Diagnostic test), also known as Balance Testing, CAPSĀ® Testing: 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 (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)

+Outcome measures

Primary outcomes

  • 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
  • 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

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (2)

FacilityCityCountryStatus
Innova Brain RehabilitationMarietta, GeorgiaUnited States
Small Street ClinicHampton, VictoriaAustralia

+Investigators