Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

Rhizarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01233739
• Other study ID #: RIZACONDRO
• Status: Recruiting
• Phase: Phase 4
• First received: November 2, 2010
• Last updated: February 21, 2013
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: Hospital Clinic of Barcelona
• Contact: Judit Pich, Pharmacist
• Phone: +34 93 227 54 00
• Email: jpich[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Spanish drugs and medical devices agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation with visual analogue pain scale as mean at the last weak		36 weeks	No
Secondary	Sollerman test	Evaluation of hand function with Sollerman test	36 weeks	No
Secondary	Hand pressure force		36 weeks	No
Secondary	Thumb-index finger pincer force		36 weeks	No
Secondary	Dash test	Osteoarthritis functional test	36 weeks	No
Secondary	SF-12 test	Quality of life test	36 weeks	No
Secondary	Mechanical sensitivity measured with electronic Von Frey filament		36 weeks	No
Secondary	vibratory and thermic sensibility threshold assisted by computer		36 weeks	No
Secondary	Use of paracetamol or other analgesic drugs	recorded in a patient diary	36 weeks	No
Secondary	Evolution of trapezium-thumb metacarpal joint by ultrasound scan		36 weeks	No
Secondary	Hematologic evaluation		24 weeks	Yes
Secondary	Biochemical evaluation		24 weeks	Yes