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Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233739
First Posted: November 3, 2010
Last Update Posted: February 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
  Purpose
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.

Condition Intervention Phase
Rhizarthrosis Drug: Chondroitin sulfate Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.

Resource links provided by NLM:


Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Evaluation with visual analogue pain scale as mean at the last weak [ Time Frame: 36 weeks ]

Secondary Outcome Measures:
  • Sollerman test [ Time Frame: 36 weeks ]
    Evaluation of hand function with Sollerman test

  • Hand pressure force [ Time Frame: 36 weeks ]
  • Thumb-index finger pincer force [ Time Frame: 36 weeks ]
  • Dash test [ Time Frame: 36 weeks ]
    Osteoarthritis functional test

  • SF-12 test [ Time Frame: 36 weeks ]
    Quality of life test

  • Mechanical sensitivity measured with electronic Von Frey filament [ Time Frame: 36 weeks ]
  • vibratory and thermic sensibility threshold assisted by computer [ Time Frame: 36 weeks ]
  • Use of paracetamol or other analgesic drugs [ Time Frame: 36 weeks ]
    recorded in a patient diary

  • Evolution of trapezium-thumb metacarpal joint by ultrasound scan [ Time Frame: 36 weeks ]
  • Hematologic evaluation [ Time Frame: 24 weeks ]
  • Biochemical evaluation [ Time Frame: 24 weeks ]

Estimated Enrollment: 108
Study Start Date: March 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Administration of 2 capsules of placebo orally.
Experimental: Chondroitin sulfate
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
Drug: Chondroitin sulfate
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.

  Eligibility

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233739


Contacts
Contact: Judit Pich, Pharmacist +34 93 227 54 00 ext 2336 jpich@clinic.ub.es

Locations
Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Catalunya, Spain, 08038
Principal Investigator: Joaquim Forés, MD         
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Principal Investigator: Joaquím Forés, MD Hospital Clínic i Provincial de Barcelona
  More Information

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01233739     History of Changes
Other Study ID Numbers: RIZACONDRO
First Submitted: November 2, 2010
First Posted: November 3, 2010
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
rhizarthrosis
Chondroitin sulfate
Placebo

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases