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OpenTrials
Completed

NCT Number: NCT02492906

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 05716-150, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteoarthrosis

Other

Primary severe knee osteoarthrosis and chronic knee pain.

healthy

Other

Healthy and non-symptomatic volunteers.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Marta Imamura

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2015
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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