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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
  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: Double Blind (Subject, Caregiver, 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Evaluation with visual analogue pain scale as mean at the last weak [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01233739     History of Changes
Other Study ID Numbers: RIZACONDRO
Study First Received: November 2, 2010
Last Updated: February 21, 2013
Health Authority: Spain: Spanish drugs and medical devices agency

Keywords provided by Hospital Clinic of Barcelona:
rhizarthrosis
Chondroitin sulfate
Placebo

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

ClinicalTrials.gov processed this record on November 27, 2014