Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2010

Last Updated Date

February 21, 2013

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01233739 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Official Title ^ICMJE

Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Rhizarthrosis

Intervention ^ICMJE

Drug: Chondroitin sulfate
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
Drug: Placebo
Administration of 2 capsules of placebo orally.

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Drug: Placebo
Experimental: Chondroitin sulfate
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.

Intervention: Drug: Chondroitin sulfate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

108

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Judit Pich, Pharmacist

+34 93 227 54 00 ext 2336

jpich@clinic.ub.es

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01233739

Other Study ID Numbers ^ICMJE

RIZACONDRO

Has Data Monitoring Committee

Responsible Party

Juan A. Arnaiz, Hospital Clinic of Barcelona

Study Sponsor ^ICMJE

Juan A. Arnaiz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joaquím Forés, MD

Hospital Clínic i Provincial de Barcelona

Information Provided By

Hospital Clinic of Barcelona

Verification Date

February 2013

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

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