Clinical trial NCT01233739: Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
Official title: Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rhizarthrosis
Keywords: rhizarthrosis
Chondroitin sulfate
Placebo
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 108
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation with visual analogue pain scale as mean at the last weak
timeFrame: 36 weeks
Secondary outcomes:
measure: Sollerman test
timeFrame: 36 weeks
measure: Hand pressure force
timeFrame: 36 weeks
measure: Thumb-index finger pincer force
timeFrame: 36 weeks
measure: Dash test
timeFrame: 36 weeks
measure: SF-12 test
timeFrame: 36 weeks
measure: Mechanical sensitivity measured with electronic Von Frey filament
timeFrame: 36 weeks
measure: vibratory and thermic sensibility threshold assisted by computer
timeFrame: 36 weeks
measure: Use of paracetamol or other analgesic drugs
timeFrame: 36 weeks
measure: Evolution of trapezium-thumb metacarpal joint by ultrasound scan
timeFrame: 36 weeks
measure: Hematologic evaluation
timeFrame: 24 weeks
measure: Biochemical evaluation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
state: Catalunya
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Joaquím Forés, MD
role: PRINCIPAL_INVESTIGATOR
References: