Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Study Overview
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Brief Summary
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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.

Official Title
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Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Drug: Chondroitin sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administration of 2 capsules of placebo orally.<br>|
| Experimental: Chondroitin sulfate<br>Administration of 2 capsules of 400 mg of chondroitin sulfate orally. | Drug: Chondroitin sulfate<br>* Administration of 2 capsules of 400 mg of chondroitin sulfate orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation with visual analogue pain scale as mean at the last weak |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sollerman test | Evaluation of hand function with Sollerman test | 36 weeks | 
| Hand pressure force |  | 36 weeks | 
| Thumb-index finger pincer force |  | 36 weeks | 
| Dash test | Osteoarthritis functional test | 36 weeks | 
| SF-12 test | Quality of life test | 36 weeks | 
| Mechanical sensitivity measured with electronic Von Frey filament |  | 36 weeks | 
| vibratory and thermic sensibility threshold assisted by computer |  | 36 weeks | 
| Use of paracetamol or other analgesic drugs | recorded in a patient diary | 36 weeks | 
| Evolution of trapezium-thumb metacarpal joint by ultrasound scan |  | 36 weeks | 
| Hematologic evaluation |  | 24 weeks | 
| Biochemical evaluation |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhizarthrosis, Chondroitin sulfate, Placebo