NCT03058003

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

February 16, 2017

Last Update Submit

August 2, 2021

Conditions

Central Nervous System Sensitization

Keywords

balance, posturalpostural equilibriumchronic painChronic nonspecific low back painFibromyalgiaCervicogenic headacheChronic tension type headacheIrritable bowel syndromeWhiplash associated disorderTemporomandibular disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • CSI-SS

    immediately after data collection

Study Arms (2)

Patients

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

Diagnostic Test: Posturography EvaluationOther: Central Sensitization Inventory

Healthy

subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory

Diagnostic Test: Posturography EvaluationOther: Central Sensitization Inventory

Interventions

Posturography EvaluationDIAGNOSTIC_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

Also known as: Balance Testing, CAPS® Testing
HealthyPatients
Central Sensitization InventoryOTHER

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)

HealthyPatients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnant women will be excluded, as will be minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Innova Brain Rehabilitation

Marietta, Georgia, 30062, United States

Location

Small Street Clinic

Hampton, Victoria, 3188, Australia

Location

MeSH Terms

Conditions

Chronic PainFibromyalgiaPost-Traumatic HeadacheIrritable Bowel SyndromeTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesJoint DiseasesStomatognathic Diseases

Study Officials

  • Paul Noone, PhD

    Caps Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 20, 2017

Study Start

May 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 1, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(1)