Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

Study Overview
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Brief Summary
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The main purposes of this study are: to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis. to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.

Official Title
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Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Chondroitin sulphate (Condrosan®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary knee OA according to ACR criteria OA of radiological stages 2 to 3 according to Kellgren-Lawrence Estable knee pain during the last months before to start the clinical trial Patients with pain as the VAS≥50mm at baseline Exclusion Criteria: Patients with skin conditions that could interfere in the clinical trial evaluation Pregnant or breastfeeding woman Patients with a history of alcoholism or other drug abuse Patients with an uncontrolled active psychiatric disorder Patients with other inflammatory or systemic conditions affecting other joints Patients who suffer more intense pain in the joint in another location Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite OA of radiological stages 1 or 4 according to Kellgren-Lawrence Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI Known allergy to chondroitin sulphate Washout period for OA treatments before beginning the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chondroitin sulphate | Drug: Chondroitin sulphate (Condrosan®)<br>* 800mg (two capsules of 400mg each) taken once a day for four months<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Two placebo capsules taken once a day for four months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain response to pain caused on arthritic knee selected by fMRI | Functional magnetic resonance imaging (fMRI) is particularly suited to investigating the effects of pharmacological agents on pain processing within the human central nervous system. The measures are based on the haemodynamic resonse to a neuronal event and constitute indirect measures of excitatory and inhibitory neuronal activity. The neuronal activation is associated with an increase of the oxygen extraction fraction from the capillaries and with an increase in regional cerebral blood flow. The measure which derived from blood oxygenation is called the BOLD effect. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the reduction of pain by Huskisson VAS |  | 4 months | 
| Determination of pain and functional capacity using the Lequesne Algofunctional Index |  | 4 months | 
| Use of rescue medication |  | 4 months | 
| Assessment of the quality of life of patients by SF-36 Health Questionaire |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging