Central Nervous System SensitizationNCT03058003
Correlation Between Central Sensitization Inventory and Posturographic Data
An observational study of Central Nervous System Sensitization, run by Caps Research Network at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Sensitization
- What is being tested?
- Posturography Evaluation and Central Sensitization Inventory
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2016to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults, self assess to be in good health or diagnosed with Central Nervous System Sensitization
Who may be able to join
- 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)
Who cannot join
- Pregnant women will be excluded, as will be minors
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Innova Brain Rehabilitation
Marietta, Georgia, 30062
About this study
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.
Read the 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
- Being tested
- Posturography Evaluation, Central Sensitization Inventory
- 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
- Medical subject headings
- Chronic Pain, Fibromyalgia, Post-Traumatic Headache, Irritable Bowel Syndrome, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posturography EvaluationDiagnostic test
Also called Balance Testing, CAPS® 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 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)
| Study group | Role | What they receive |
|---|---|---|
| Patients | subjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory Receives: Diagnostic Test: Posturography Evaluation; Other: Central Sensitization Inventory | |
| Healthy | subjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory Receives: Diagnostic Test: Posturography Evaluation; Other: Central Sensitization Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: immediately after data collection
Secondary outcomes (1)
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
Measured: immediately after data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startMay 2016
- Primary completionJan 2018
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System SensitizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caps Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Noone, PhD, Principal investigator, Caps Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058003
- Sponsor's protocol ID
- CI-IRB-20170124001
- Status last verified
- Aug 2021
- First submitted
- 16 Feb 2017
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Central Sensitization Inventory and Posturographic Data
- ClinicalTrials.gov ID
- NCT03058003
- Acronym / sponsor ID
- CI-IRB-20170124001
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Caps Research NetworkUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Posturography Evaluation, Other: Central Sensitization Inventorysubjects suffering from chronic pain undergoing Posturography Evaluation and Central Sensitization Inventory |
| Healthy | – | Diagnostic Test: Posturography Evaluation, Other: Central Sensitization Inventorysubjects self assessed to be in good health undergoing Posturography Evaluation and Central Sensitization Inventory |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, self assess to be in good health or diagnosed with Central Nervous System Sensitization
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Pregnant women will be excluded, as will be minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posturography EvaluationAlso: Balance Testing, CAPS® TestingPosturography 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 | Diagnostic test | Healthy, Patients |
| Central Sensitization InventoryStandard chronic pain questionnaire: the subjects will be required to score each of the 25 items on a scale from 0 (never) to 4 (always) | Other | Healthy, Patients |
Primary outcome
Stability Score
Time frame: 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
Time frame: 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
1 secondary outcome
CSI-SS
Time frame: immediately after data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Central Nervous System Sensitization
RecruitingObservational study
Postoperative Pain Trajectories After Endometriosis Surgery
Endometriosis, Postoperative Pain
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
RecruitingObservational study
The Role of Interoceptive Sensitivity in Central Sensitization Symptom Severity in Fibromyalgia
Fibromyalgia, Interoception
Not yet recruiting
the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis (RA), Transcutaneous Vagus Nerve Stimulation
Not yet recruiting
Pain Neuroscience Education and Neuromuscular Exercise in Individuals With Chronic Low Back Pain and Central Sensitization
Low Back Pain, Chronic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Noone, PhD principal investigator
Caps Research Network
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Sensitization, run by Caps Research Network at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability Score (time frame: immediately after data collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.