Knee Osteoarthritis
Conditions
Keywords
Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging
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.
Interventions
DRUGChondroitin sulphate (Condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months
DRUGPlacebo
Two placebo capsules taken once a day for four months.
Sponsors
Bioiberica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed