Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Karlsson score
研究概览
简要总结
The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness.
There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.
详细描述
This study is designed as a single blind prospective randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grade II and III acute lateral ankle ligament injuries. The patients will be randomly allocated into one of the three groups. Randomization will be performed by computer. Blinding of patients is not possible, but the observer will be blinded at eight weeks and six months.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years
- •Grade II or III ankle sprains
- •Presentation < 72 hours after the acute injury
排除标准
- •Patients with a history of chronic instability
- •Who had a fracture on X-ray investigation
- •Other injuries or disabilities on the same limb
- •Alcoholism, serious psychiatric and neurological illness
- •Patients with bilaterally sprained ankles
- •Patients with previous surgery on the lateral ankle ligaments
- •Skin diseases where taping is not practicable
- •Patients who are unable to give informed consent
- •Patients who are unable to fill out questionnaires
- •Neuromuscular disorders of the lower extremities
- •Active rheumatoid arthritis
- •Gait disturbances
结局指标
主要结局
Karlsson score
时间窗: up to 6 months FU
The patients were asked to fill out a questionnaire regarding the function of the ankle joint. The score includes eight items based on a subjective evaluation of stability, pain, swelling and stiffness in relation to activities of everyday life, sports and recreational activities, running, stair climbing and working ability. The maximum score is 100 points.
次要结局
- Return to work(up to 6 months FU)
- Return to sports(up to 6 months FU)
- Pain VAS(up to 6 months FU)
- Range of motion (ROM)(up to 6 months FU)
- Recurrent inversion injury(up to 6 months FU)
- Complications / adverse events(up to 6 months FU)
- Tegner activity level(up to 6 months FU)
- EuroQol (EQ5D)(up to 6 months FU)
- Costeffectiveness(up to 6 months FU)
- Compliance(up to 6 months FU)
- FAOS(up to 6 months FU)
- Objective stability(up to 6 months FU)
研究者
Michel P. J. van den Bekerom
MD
Gelre Hospitals