Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01233739
First received: November 2, 2010
Last updated: February 21, 2013
Last verified: February 2013

November 2, 2010
February 21, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
Evaluation with visual analogue pain scale as mean at the last weak [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01233739 on ClinicalTrials.gov Archive Site
  • Sollerman test [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Evaluation of hand function with Sollerman test
  • Hand pressure force [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Thumb-index finger pincer force [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Dash test [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Osteoarthritis functional test
  • SF-12 test [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Quality of life test
  • Mechanical sensitivity measured with electronic Von Frey filament [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • vibratory and thermic sensibility threshold assisted by computer [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Use of paracetamol or other analgesic drugs [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    recorded in a patient diary
  • Evolution of trapezium-thumb metacarpal joint by ultrasound scan [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Hematologic evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Biochemical evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhizarthrosis
  • Drug: Chondroitin sulfate
    Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
  • Drug: Placebo
    Administration of 2 capsules of placebo orally.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Chondroitin sulfate
    Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
    Intervention: Drug: Chondroitin sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
No
Contact: Judit Pich, Pharmacist +34 93 227 54 00 ext 2336 jpich@clinic.ub.es
Spain
 
NCT01233739
RIZACONDRO
No
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Principal Investigator: Joaquím Forés, MD Hospital Clínic i Provincial de Barcelona
Hospital Clinic of Barcelona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP