Medial-Wedge Insole is Highly Effective in the Treatment of Valgus Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 主要终点
- To assess symptoms, Visual Analog Scale (VAS) will be used for night pain, pain at rest and on movement. Lequesne index score and the WOMAC questionnaire will be applied at baseline and after 8 weeks by a blinded examiner.
研究概览
简要总结
- To assess the efficacy of medial-wedge insole in valgus knee osteoarthritis (OA).
- We hypothesized that medial-wedged insoles are biomechanically effective and should reduce lateral compartment loading in persons with valgus knee osteoarthritis with a consequent symptomatic improvement.
详细描述
Thirty females fulfilling the American College of Rheumatology criteria for knee osteoarthritis with bilateral valgus deformity greater than or equal to 8° were consecutively will be selected from the Rheumatology Outpatient Clinic of University of São Paulo. Radiographic grading of OA was defined according to Kellgren and Lawrence (KL) and analyzed blind by the same rheumatologist. Inclusion criteria were knee osteoarthritis with lateral compartment involvement detected on X-Ray (KL class II or more); absence or minimal (KL class 0 or I) for medial compartment involvement; and pain on movement > 2 measured by Visual Analog Scale (VAS).
Exclusion criteria were: body mass index (BMI) > 40, scoliosis, lower limbs length difference exceeding 1 cm, knee surgery, hallux rigidus, previous history of rheumatologic disease (rheumatoid arthritis, connective tissue disease, microcrystalline arthropathy, and soronegative arthropathy), soft tissue involvement (anserine, patellar, and calcaneal tendinopathy), and foot/lower leg symptoms.
Corticosteroid and hyaluronic acid infiltrations were not allowed 3 and 6 months prior to entry, respectively. The use of non-steroidal anti-inflammatory and analgesics or slow action drugs (DMARDs) were allowed if prescribed at least four weeks and eight weeks before entry and remained unchanged throughout the study.
The study was approved by the local Ethical Committee and all patients signed informed consent.
Study protocol:
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
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •knee osteoarthritis with bilateral valgus deformity greater than or equal to 8°.
- •Radiographic grading of OA was defined according to Kellgren and Lawrence (KL)class II or more
- •pain on movement > 2 measured by Visual Analog Scale (VAS).
排除标准
- •body mass index (BMI) > 40
- •scoliosis
- •lower limbs length difference exceeding 1 cm
- •knee surgery
- •hallux rigidus
- •previous history of rheumatologic disease (rheumatoid arthritis, connective tissue disease, microcrystalline arthropathy,soronegative arthropathy)
- •soft tissue involvement (anserine, patellar, and calcaneal tendinopathy)
- •foot/lower leg symptoms
结局指标
主要结局
To assess symptoms, Visual Analog Scale (VAS) will be used for night pain, pain at rest and on movement. Lequesne index score and the WOMAC questionnaire will be applied at baseline and after 8 weeks by a blinded examiner.
时间窗: 2 years
次要结局
- Antero-posterior conventional X-ray of knees and ankles were both performed under monopodalic load with and without insoles in order to measure femorotibial, talocalcaneal, and talus tilt angles.(2 years)