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

NCT02492906 | Completed DMC

• 1 other identifier: Osteoarthrosis Neuroimaging
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline at time of evaluation.

Secondary Outcomes (2)

• VAS Comparison

  Baseline at time of evaluation.

• Pressure Pain Threshold Comparison

  Baseline at time of evaluation.

Study Arms (2)

Osteoarthrosis group

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

Other: Osteoarthrosis

Healthy patients

Healthy patients

Other: Healthy

Interventions

Osteoarthrosis OTHER

Primary severe knee osteoarthrosis and chronic knee pain.

Osteoarthrosis group

Healthy OTHER

Healthy and non-symptomatic volunteers.

Healthy patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marta Imamura: lead

Study Sites (1)

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ORALIT

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marta Imamura, MD

  Instituto de Medicina Física e Reabilitação HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator of the Clinical Research Site of Institute of Physical and Rehabilitation Medicine of HC FMUSP

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 9, 2015
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

BR (1)