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Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry

Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02492906
Enrollment
56
Registered
2015-07-09
Start date
2011-04-30
Completion date
2013-04-30
Last updated
2015-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief 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 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.

Interventions

OTHEROsteoarthrosis

Primary severe knee osteoarthrosis and chronic knee pain.

OTHERHealthy

Healthy and non-symptomatic volunteers.

Sponsors

Marta Imamura
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Volumetry ComparisonBaseline 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.

Secondary

MeasureTime frameDescription
VAS ComparisonBaseline at time of evaluation.Self rated Visual Analogue Scale for pain comparison between the healthy and the Knee Osteoarthrosis Group.
Pressure Pain Threshold ComparisonBaseline at time of evaluation.Pressure algometry on the patients' back and lower limbs for comparison between the healthy and the Knee Osteoarthrosis Group.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026