- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02492906
Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05716-150
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Osteoarthrosis group
Patients with primary severe knee osteoarthrosis or with chronic knee pain.
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Primary severe knee osteoarthrosis and chronic knee pain.
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Healthy patients
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Healthy and non-symptomatic volunteers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline at time of evaluation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS Comparison
Time Frame: Baseline at time of evaluation.
|
Self rated Visual Analogue Scale for pain comparison between the healthy and the Knee Osteoarthrosis Group.
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Baseline at time of evaluation.
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Pressure Pain Threshold Comparison
Time Frame: Baseline at time of evaluation.
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Pressure algometry on the patients' back and lower limbs for comparison between the healthy and the Knee Osteoarthrosis Group.
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Baseline at time of evaluation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osteoarthrosis Neuroimaging
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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