Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Analogical Visual Scale of Pain (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Infiltration of corticosteroids
干预措施: infiltration of corticosteroids (Drug)
Infiltration of corticosteroids and hyaluronic acid
干预措施: infiltration of corticosteroids and hyaluronic acid (Drug)
结局指标
主要结局
Analogical Visual Scale of Pain (VAS)
时间窗: 3 month post infiltration
Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
次要结局
未报告次要终点