Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Ankle Osteoarthritis Scale (AOS) score
研究概览
简要总结
The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.
详细描述
Recent pilot studies report that intraarticular injection of Botulinum Toxin A into painful joints of patients with various types of arthritis leads to significant and durable improvement in pain and function and is safe to use. To date, there is no published literature that evaluate the effects of intraarticular Botulinum Toxin A in the treatment of ankle OA. Sun el al reported that 3 or 5 weekly injection of hyaluronate may improve pain and physical function in patients with ankle OA and the treatment effects may last for 6 months. The effect of one injection of hyaluronate plus exercise had never been studied. The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise for patients with ankle OA.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age of 20-85 years with diagnosis of ankle osteoarthritis
- •unilateral ankle pain that had lasted for at least 6 months, with no significant benefit from conservative treatment or with an inability to tolerate the side effects of medications
- •ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system
- •a current total Ankle Osteoarthritis Scale (AOS) score of >3 and < 9 (possible range, 0-10)
- •a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane
- •no changes in shoes or orthotic devices during the study period.
排除标准
- •pregnancy or lactation in women
- •lower leg trauma other than ankle trauma
- •previous surgery involving the spine, hip or knee
- •the presence of an active joint infections of foot or ankle
- •previous surgery or arthroscopy on the ankle within 12 months
- •history of chicken or egg allergy
- •intraarticular steroid or hyaluronate injection in the treated ankle within the previous 6 months
- •treatment with anticoagulants or immunosuppressives
- •a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
- •the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or recent trauma) or poor health status that would interfere with the clinical assessments during the study.
研究组 & 干预措施
The Botulinum Toxin A group
The Botulinum Toxin A group received intraarticular injections of 100 units of Botulinum Toxin A (Allergan, Inc, Irvine CA) reconstituted in 2 cc normal saline.
干预措施: Botulinum Toxin A (Allergan, Inc, Irvine CA) (Drug)
The hyaluronate group (Hyalgan, Italy)
The hyaluronate group received intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, molecular weight 500-730kDa, Fidia Pharmaceutical Corporation, Abano Terme, Italy) and subsequent 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise for 2 weeks .
干预措施: Hyalgan (Hyalgan, Fidia , Italy) (Drug)
结局指标
主要结局
Ankle Osteoarthritis Scale (AOS) score
时间窗: at 6 months after the injection
The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale.Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
次要结局
- adverse effects(at 2 weeks, 1 month, 3 months, and 6 months post injection.)
- AOFAS ankle/hindfoot score(pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.)
- Visual analog scale (VAS)(pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection)
- Single-leg stance test (SLS)(pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection)
- Timed " Up-and-Go" test (TUG)(pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection)
- global Patients satisfaction(at 2 weeks, 1 month, 3 months, and 6 months post injection.)
研究者
Shu-Fen Sun
MD
Kaohsiung Veterans General Hospital.