Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

Study Overview
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Brief Summary
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The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis. The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid. No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.

Official Title
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Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Drug: infiltration of corticosteroids
* Drug: infiltration of corticosteroids and hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, ≥ 40 years Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint: marginal osteophyte pinching of the joint space sclerosis of the subchondral space subchondral kyst absence of osteopenia Patient with the ability to understand the protocol and signed informed consent Patient receiving social security Exclusion Criteria: Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol) Change of analgesic treatment within 4 weeks before inclusion. Patients with symptomatic bilateral rhizarthrosis Scaphoid-trapezial arthrosis Local or general infection Severe coagulation disorders, ongoing anticoagulant therapy severe and / or uncontrolled hypertension Earlier local surgery Associated inflammatory rheumatism Tendinopathy of De Quervain, thumb to jump associated Infiltrations earlier than 6 months Diabetes imbalanced Live vaccines Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure) Pregnant or lactating women Immunocompromised or hemodialysis patients Patients under guardianship, trusteeship, or deprived of liberty Patients participating in another clinical research protocol involving a drug or medical device Patients unable to follow the protocol, according to the judgment of the investigator

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infiltration of corticosteroids<br> | Drug: infiltration of corticosteroids<br>* infiltration of corticosteroids<br>|
| Experimental: Infiltration of corticosteroids and hyaluronic acid<br> | Drug: infiltration of corticosteroids and hyaluronic acid<br>* infiltration of corticosteroids and hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analogical visual scale of pain (VAS) | Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable) | 3 month post infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of pain to activity at protocol follow-up visits | Analogical visual scale of pain (VAS) | 1 month, 6 month, and 12 month post infiltration | 
| Progression of pain at rest at protocol follow-up visits | Analogical visual scale of pain (VAS) | Base-line,1 month, 3month, 6 month, and 12 month post infiltration | 
| Comparison of pain between M0 and M3, by weekly collection on a patient book | Analogical visual scale of pain (VAS) | 3 month post infiltration | 
| Evolution of the fhand unction with Cochin Hand Function Scale | Cochin Hand Function Scale | 1 month, 6 month, and 12 month post infiltration | 
| Evolution of the grip and opposition force | dynamometer mesures | 1 month, 3 month, 6 month, and 12 month post infiltration | 
| Ultrasound appearance of lesions | ultrasound b-mode and Doppler - gradation of OMERACT | Baseline and 3 month post infiltration | 
| Comparison of infiltration pain | Analogical visual scale of pain (VAS) | the day of infiltration | 
| Patient's feelings about the evolution of his pain | Verbal Scale of global evolution | 3 month post infiltration | 
| Need for new infiltrations | Number of corticosteroid infiltrations | over the 12 months of follow-up | 
| Use of analgesics and NSAIDs | Use of analgesics and NSAIDs | over the 12 months of follow-up | 
| Need for surgical procedure | Number of patient requiring a surgical procedure | over the 12 months of follow-up | 
| Number of days off work | Number of days off work | over the 12 months of follow-up |