Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
- Registration Number
- NCT01233739
- Lead Sponsor
- Juan A. Arnaiz
- 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 indicators of pain and sensibility.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 108
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Chondroitin sulfate Chondroitin sulfate Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
- Primary Outcome Measures
Name Time Method Evaluation with visual analogue pain scale as mean at the last weak 36 weeks
- Secondary Outcome Measures
Name Time Method SF-12 test 36 weeks Quality of life test
Thumb-index finger pincer force 36 weeks Dash test 36 weeks Osteoarthritis functional test
Sollerman test 36 weeks Evaluation of hand function with Sollerman test
Hand pressure force 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 36 weeks recorded in a patient diary
Evolution of trapezium-thumb metacarpal joint by ultrasound scan 36 weeks Hematologic evaluation 24 weeks Biochemical evaluation 24 weeks
Trial Locations
- Locations (1)
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Catalunya, Spain