Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Juan A. Arnaiz

Status and phase

Unknown

Phase 4

Conditions

Rhizarthrosis

Treatments

Drug: Placebo

Drug: Chondroitin sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT01233739

RIZACONDRO

Details and patient eligibility

About

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 indicators of pain and sensibility.

Enrollment

108 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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