Clinical trial NCT03058003: Correlation Between Central Sensitization Inventory and Posturographic Data
Official title: Correlation Between Central Sensitization Inventory and Posturographic Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Sensitization
Keywords: balance, postural
postural equilibrium
chronic pain
Chronic nonspecific low back pain
Fibromyalgia
Cervicogenic headache
Chronic tension type headache
Irritable bowel syndrome
Whiplash associated disorder
Temporomandibular disorder
Lead sponsor: Caps Research Network
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, self assess to be in good health or diagnosed with Central Nervous System Sensitization

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.

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

Primary outcomes:
measure: Stability Score
timeFrame: immediately after data collection
measure: CSI
timeFrame: immediately after data collection
Secondary outcomes:
measure: CSI-SS
timeFrame: immediately after data collection
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Innova Brain Rehabilitation
state: Georgia
city: Hampton
country: Australia
facility: Small Street Clinic
state: Victoria
Study officials:
affiliation: Caps Research Network
name: Paul Noone, PhD
role: PRINCIPAL_INVESTIGATOR
References: