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

Phase 4

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Chondroitin sulphate (Condrosan®); Drug: Placebo

• Registration Number: NCT01226615
• Lead Sponsor: Bioiberica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2011-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chondroitin sulphate (Condrosan®)	Chondroitin sulphate
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Brain response to pain caused on arthritic knee selected by fMRI	4 months	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain