Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
Primary Purpose
Rhizarthrosis
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Chondroitin sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhizarthrosis focused on measuring rhizarthrosis, Chondroitin sulfate, Placebo
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
Sites / Locations
- Hospital Clínic i Provincial de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Chondroitin sulfate
Arm Description
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
Outcomes
Primary Outcome Measures
Evaluation with visual analogue pain scale as mean at the last weak
Secondary Outcome Measures
Sollerman test
Evaluation of hand function with Sollerman test
Hand pressure force
Thumb-index finger pincer force
Dash test
Osteoarthritis functional test
SF-12 test
Quality of life test
Mechanical sensitivity measured with electronic Von Frey filament
vibratory and thermic sensibility threshold assisted by computer
Use of paracetamol or other analgesic drugs
recorded in a patient diary
Evolution of trapezium-thumb metacarpal joint by ultrasound scan
Hematologic evaluation
Biochemical evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01233739
Brief Title
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
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis
Keywords
rhizarthrosis, Chondroitin sulfate, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Chondroitin sulfate
Arm Type
Experimental
Arm Description
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
Intervention Type
Drug
Intervention Name(s)
Chondroitin sulfate
Intervention Description
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of 2 capsules of placebo orally.
Primary Outcome Measure Information:
Title
Evaluation with visual analogue pain scale as mean at the last weak
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Sollerman test
Description
Evaluation of hand function with Sollerman test
Time Frame
36 weeks
Title
Hand pressure force
Time Frame
36 weeks
Title
Thumb-index finger pincer force
Time Frame
36 weeks
Title
Dash test
Description
Osteoarthritis functional test
Time Frame
36 weeks
Title
SF-12 test
Description
Quality of life test
Time Frame
36 weeks
Title
Mechanical sensitivity measured with electronic Von Frey filament
Time Frame
36 weeks
Title
vibratory and thermic sensibility threshold assisted by computer
Time Frame
36 weeks
Title
Use of paracetamol or other analgesic drugs
Description
recorded in a patient diary
Time Frame
36 weeks
Title
Evolution of trapezium-thumb metacarpal joint by ultrasound scan
Time Frame
36 weeks
Title
Hematologic evaluation
Time Frame
24 weeks
Title
Biochemical evaluation
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judit Pich, Pharmacist
Phone
+34 93 227 54 00
Ext
2336
Email
jpich@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquím Forés, MD
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08038
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquim Forés, MD
12. IPD Sharing Statement
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Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
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