Status:
UNKNOWN
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
Lead Sponsor:
Juan A. Arnaiz
Conditions:
Rhizarthrosis
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective in...
Eligibility Criteria
Inclusion
- both sex patients
- age between 45 to 75 years
- with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
- grade II or III Eaton \& Glickel rhizarthrosis radiological diagnose
- pain at inclusion of \>= 40 mm at a visual analogue scale
- without rehabilitation treatment or infiltration in the last 6 months
- who accept to participate and sign informed consent
Exclusion
- patients with rhizarthrosis resulted from rheumatic disease
- patients with joint surgery or traumatic background
- illiterate patients or unable to understand informed consent
- patients with previous neuropsychopathology enough severe to unable participation at the study
- patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
- patients with coagulopathy
- inflammation for other process at the joint at study
- in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
- allergy or hypersensibility at chondroitin sulfate or its excipients
- pregnant or breastfeeding woman
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01233739
Start Date
March 1 2011
End Date
April 1 2013
Last Update
February 22 2013
Active Locations (1)
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1
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08038