Clinical trial NCT01226615: Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)
Official title: Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Chondroitin sulphate
Knee osteoarthritis
Functional Magnetic Resonance Imaging
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Brain response to pain caused on arthritic knee selected by fMRI
timeFrame: 4 months
Secondary outcomes:
measure: Assessment of the reduction of pain by Huskisson VAS
timeFrame: 4 months
measure: Determination of pain and functional capacity using the Lequesne Algofunctional Index
timeFrame: 4 months
measure: Use of rescue medication
timeFrame: 4 months
measure: Assessment of the quality of life of patients by SF-36 Health Questionaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Jordi Monfort, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Jesús Pujol, MD
role: PRINCIPAL_INVESTIGATOR
References: