ACTRN12620000732987尚未招募4 期
Effectiveness of intra-articular hyaluronic acid compared to corticosteroid or placebo injections to treat basal thumb osteoarthritis: a prospective, randomised, blinded clinical study
Prof. Warren Rozen0 个研究点目标入组 90 人开始时间: 2020年7月13日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit(—)
- 性别
- All
入选标准
- •Participants eligible for the trial must comply with all of the following at randomization:
- •1.Age greater or equal to 40 years
- •2.Symptomatic 1st carpometacarpal osteoarthritis requiring non-operative treatment, diagnosed by both standard clinical and radiographic measures as below
- •a.Clinical osteoarthritis includes the following
- •i.History of carpometacarpal tenderness, thumb or wrist pain at rest or with activity, joint stiffness or decreased function
- •ii.Examination yielding dorsoradial prominence of the thumb metacarpal base, tenderness over the joint, crepitus, positive grind” test or positive distraction” test
- •b.Radiographic evidence of osteoarthritis of any Eaton-Littler-Burton classification
- •Patients who have received previous injections to the carpometacarpal joint to be treated of either hyaluronic acid or steroid will be included if they have had 1 or 2 prior injections with reported improvement in pain and function after the injections as they will be likely to have benefit from a further injection.
排除标准
- •1.Prior surgery to affected thumb/wrist
- •2.Injury to joint in last 6 months
- •3.Prior or current infection in affected joint
- •4.History of inflammatory arthritis or skin disease at the injection site
- •5.Pre-existing chondrocalcinosis, thoracic outlet syndrome, carpal tunnel syndrome, Guyon’s canal syndrome, cubital tunnel syndrome, diabetic neuropathy or cheiroarthropathy, palmar tenosynovitis, trigger thumb, fibromyalgia, pain syndrome, psoriasis
- •6.Pregnant or lactating women
- •7.Known allergy to local anaesthetic, cortisone or hyaluronic acid derivative products
- •8.Visual Analogue Scale <40mm
- •9.Regular opiate use for a concomitant condition or analgesics unless stable dosage for over or equal to 1 month
- •10.If participants have had more than 2 injections of either hyaluronic acid or corticosteroid to the first carpometacarpal joint or an injection in the last 6 months.
研究者
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