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

NCT ID: NCT02492906

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-04-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Osteoarthrosis group

Patients with primary severe knee osteoarthrosis or with chronic knee pain.

Osteoarthrosis

Intervention Type: OTHER

Primary severe knee osteoarthrosis and chronic knee pain.

Healthy patients

Healthy patients

Healthy

Intervention Type: OTHER

Healthy and non-symptomatic volunteers.

Interventions

Osteoarthrosis

Primary severe knee osteoarthrosis and chronic knee pain.

Intervention Type: OTHER

Healthy

Healthy and non-symptomatic volunteers.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

Coordinator of the Clinical Research Site of Institute of Physical and Rehabilitation Medicine of HC FMUSP

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Física e Reabilitação HCFMUSP

Locations

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Osteoarthrosis Neuroimaging

Identifier Type: -

Identifier Source: org_study_id