Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)
|ClinicalTrials.gov Identifier: NCT01226615|
Recruitment Status : Unknown
Verified October 2012 by Bioiberica.
Recruitment status was: Active, not recruiting
First Posted : October 22, 2010
Last Update Posted : October 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: Chondroitin sulphate (Condrosan®) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||October 2010|
|Actual Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||December 2012|
Drug: Chondroitin sulphate (Condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months
Placebo Comparator: 2
Two placebo capsules taken once a day for four months.
- Brain response to pain caused on arthritic knee selected by fMRI [ Time Frame: 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.
- Assessment of the reduction of pain by Huskisson VAS [ Time Frame: 4 months ]
- Determination of pain and functional capacity using the Lequesne Algofunctional Index [ Time Frame: 4 months ]
- Use of rescue medication [ Time Frame: 4 months ]
- Assessment of the quality of life of patients by SF-36 Health Questionaire [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226615
|Hospital del Mar|
|Principal Investigator:||Jordi Monfort, MD||Hospital del Mar|
|Principal Investigator:||Jesús Pujol, MD||Hospital del Mar|