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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492906
• Other study ID #: Osteoarthrosis Neuroimaging
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: July 6, 2015
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Osteoarthrosis
Primary severe knee osteoarthrosis and chronic knee pain.
• Healthy
Healthy and non-symptomatic volunteers.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Fisica e Reabilitacao HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marta Imamura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	VAS Comparison	Self rated Visual Analogue Scale for pain comparison between the healthy and the Knee Osteoarthrosis Group.	Baseline at time of evaluation.	No
Secondary	Pressure Pain Threshold Comparison	Pressure algometry on the patients' back and lower limbs for comparison between the healthy and the Knee Osteoarthrosis Group.	Baseline at time of evaluation.	No