Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

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

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.

Study Overview

• Status: Unknown
• Conditions: Rhizarthrosis
• Intervention / Treatment: Drug: Placebo; Drug: Chondroitin sulfate

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Judit Pich, Pharmacist; Phone Number: 2336 +34 93 227 54 00; Email: jpich@clinic.ub.es

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08038
      • Recruiting
      • Hospital Clinic i Provincial de Barcelona
      • Principal Investigator: Joaquim Forés, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation with visual analogue pain scale as mean at the last weak	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sollerman test	Evaluation of hand function with Sollerman test	36 weeks
Hand pressure force		36 weeks
Thumb-index finger pincer force		36 weeks
Dash test	Osteoarthritis functional test	36 weeks
SF-12 test	Quality of life test	36 weeks
Mechanical sensitivity measured with electronic Von Frey filament		36 weeks
vibratory and thermic sensibility threshold assisted by computer		36 weeks
Use of paracetamol or other analgesic drugs	recorded in a patient diary	36 weeks
Evolution of trapezium-thumb metacarpal joint by ultrasound scan		36 weeks
Hematologic evaluation		24 weeks
Biochemical evaluation		24 weeks

Collaborators and Investigators

• Sponsor: Juan A. Arnaiz
• Investigators: Principal Investigator: Joaquím Forés, MD, Hospital Clinic i Provincial de Barcelona

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Placebo; rhizarthrosis; Chondroitin sulfate
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: RIZACONDRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No