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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioiberica

Criteria

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