Rhizarthrosis
Conditions
Keywords
rhizarthrosis, Chondroitin sulfate, Placebo
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.
Interventions
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
DRUGPlacebo
Administration of 2 capsules of placebo orally.
Sponsors
Juan A. Arnaiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation with visual analogue pain scale as mean at the last weak | 36 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand pressure force | 36 weeks | — |
| Thumb-index finger pincer force | 36 weeks | — |
| Dash test | 36 weeks | Osteoarthritis functional test |
| SF-12 test | 36 weeks | Quality of life test |
| Mechanical sensitivity measured with electronic Von Frey filament | 36 weeks | — |
| Sollerman test | 36 weeks | Evaluation of hand function with Sollerman test |
| 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 | — |
| vibratory and thermic sensibility threshold assisted by computer | 36 weeks | — |
Countries
Spain
Contacts
Primary ContactJudit Pich, Pharmacist
Outcome results
None listed