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Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Primary Purpose

Rhizarthrosis

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Chondroitin sulfate

Placebo

About this trial

This is an interventional treatment trial for Rhizarthrosis focused on measuring rhizarthrosis, Chondroitin sulfate, Placebo

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01233739

First Posted

November 2, 2010

Last Updated

February 21, 2013

Sponsor

Juan A. Arnaiz

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

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

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

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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