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

July 6, 2015 updated by: Marta Imamura
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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 05716-150
        • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy patients and patients with primary severe knee osteoarthrosis and with chronic knee pain were included.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Primary severe knee osteoarthrosis and chronic knee pain.
Healthy patients
Healthy and non-symptomatic volunteers.

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.
Baseline at time of evaluation.

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.
Baseline at time of evaluation.
Pressure Pain Threshold Comparison
Time Frame: Baseline at time of evaluation.
Pressure algometry on the patients' back and lower limbs for comparison between the healthy and the Knee Osteoarthrosis Group.
Baseline at time of evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

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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