Osteoarthritis, KneeNCT02492906
Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry
An observational study of Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
Trial summary
Due to scarce published articles about this subject, the researchers aim to study the volume measurements of the brain cortex of patients with primary severe knee osteoarthrosis and those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating the neuroimaging of cerebral volumetry with… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Osteoarthrosis and Healthy
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Apr 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients and patients with primary severe knee osteoarthrosis and with chronic knee pain were included.
Who may be able to join
- Age above 60 years old;
- Both genders;
- Clinical diagnosis of knee osteoarthrosis;
- Self-rated VAS moderate to severe (VAS > 4);
- Pain duration longer than 3 months prior to the evaluation;
- Signed Informed Consent;
- Light physical activity practice or sedentary (healthy volunteers only).
Who cannot join
- Presence of psychiatric disorders;
- Presence of fibromyalgia;
- Presence of rheumatologic diseases;
- Presence of previous knee surgery;
- Presence of clinical symptoms (healthy volunteers only);
- Presence of knee pain on the previous 6 months (healthy volunteers only);
- History of neoplasia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, São Paulo, 05716-150
About this study
Due to scarce published articles about this subject, the researchers aim to study the volume measurements of the brain cortex of patients with primary severe knee osteoarthrosis and those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and pressure pain threshold.
Read the detailed description
The protocol was designed to include 31 patients in each observational arm, either patients with severe knee osteoarthrosis and chronic knee pain or healthy and non-symptomatic volunteers.
The researchers performed anamnesis to collect clinical and demographic information, the intensity of pain was assessed by the self-rated Visual Analogue Scale (VAS), the pressure pain threshold was evaluated with an algometer, the knee function was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and the images were collected with the use of the Magnetic Resonance.
Covariates, such as age, gender, Body Mass Index (BMI) and comorbidities as diabetes, cardiac diseases, pulmonary diseases, endocrine diseases and the practice of physical activities were also collected.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Osteoarthrosis, Healthy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoarthrosisOther
Primary severe knee osteoarthrosis and chronic knee pain.
HealthyOther
Healthy and non-symptomatic volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthrosis group | Patients with primary severe knee osteoarthrosis or with chronic knee pain. Receives: Other: Osteoarthrosis | |
| Healthy patients | Healthy patients Receives: Other: Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Volumetry Comparison
Brain Magnetic Resonance on axial Fluid Attenuated Inversion Recovery (FLAIR) and axial volume comparison between the healthy and the Knee Osteoarthrosis Group.
Measured: Baseline at time of evaluation.
Secondary outcomes (2)
VAS Comparison
Self rated Visual Analogue Scale for pain comparison between the healthy and the Knee Osteoarthrosis Group.
Measured: Baseline at time of evaluation.
Pressure Pain Threshold Comparison
Pressure algometry on the patients' back and lower limbs for comparison between the healthy and the Knee Osteoarthrosis Group.
Measured: Baseline at time of evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD, Principal investigator, Instituto de Medicina Física e Reabilitação HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492906
- Sponsor's protocol ID
- Osteoarthrosis Neuroimaging
- Status last verified
- Jul 2015
- First submitted
- 29 Jun 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry
- ClinicalTrials.gov ID
- NCT02492906
- Acronym / sponsor ID
- Osteoarthrosis Neuroimaging
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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.
Due to scarce published articles about this subject, the researchers aim to study the volume measurements of the brain cortex of patients with primary severe knee osteoarthrosis and those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and pressure pain threshold.
Detailed description
The protocol was designed to include 31 patients in each observational arm, either patients with severe knee osteoarthrosis and chronic knee pain or healthy and non-symptomatic volunteers.
The researchers performed anamnesis to collect clinical and demographic information, the intensity of pain was assessed by the self-rated Visual Analogue Scale (VAS), the pressure pain threshold was evaluated with an algometer, the knee function was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and the images were collected with the use of the Magnetic Resonance.
Covariates, such as age, gender, Body Mass Index (BMI) and comorbidities as diabetes, cardiac diseases, pulmonary diseases, endocrine diseases and the practice of physical activities were also collected.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthrosis group | – | Other: OsteoarthrosisPatients with primary severe knee osteoarthrosis or with chronic knee pain. |
| Healthy patients | – | Other: HealthyHealthy patients |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients and patients with primary severe knee osteoarthrosis and with chronic knee pain were included.
Key inclusion criteria (7 listed)
- Age above 60 years old;
- Both genders;
- Clinical diagnosis of knee osteoarthrosis;
- Self-rated VAS moderate to severe (VAS > 4);
- Pain duration longer than 3 months prior to the evaluation;
Key exclusion criteria (7 listed)
- Presence of psychiatric disorders;
- Presence of fibromyalgia;
- Presence of rheumatologic diseases;
- Presence of previous knee surgery;
- Presence of clinical symptoms (healthy volunteers only);
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 |
|---|---|---|
| OsteoarthrosisPrimary severe knee osteoarthrosis and chronic knee pain. | Other | Osteoarthrosis group |
| HealthyHealthy and non-symptomatic volunteers. | Other | Healthy patients |
Primary outcome
Cerebral Volumetry Comparison
Time frame: Baseline at time of evaluation.
Brain Magnetic Resonance on axial Fluid Attenuated Inversion Recovery (FLAIR) and axial volume comparison between the healthy and the Knee Osteoarthrosis Group.
2 secondary outcomes
VAS Comparison
Time frame: Baseline at time of evaluation.
Pressure Pain Threshold Comparison
Time frame: Baseline at time of evaluation.
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 9 Jul 2015.
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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.
Marta Imamura, MD principal investigator
Instituto de Medicina Física e Reabilitação HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
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 7 inclusion and 7 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Cerebral Volumetry Comparison (time frame: Baseline at time of evaluation.). 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 9 Jul 2015.