Comparison of Efficacy of Biofeedback, Electrical Stimulation and Therapeutic Exercise in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS).
研究概览
简要总结
Osteoarthritis (OA) is a chronic joint disease that involves the entire joint, causing cartilage damage, bone remodeling, osteophyte formation and loss of normal joint function. Knee OA is one of the leading causes of disability in the world and thus represents a major public health problem. Knee OA treatment can be operative and non-operative. Non-operative treatment includes pharmacological treatment, changing life style and physical therapy. The goal of physical therapy in knee OA is to reduce pain and improve knee function through therapeutic exercise, especially by strengthening the quadriceps muscle. In addition to therapeutic exercise, muscle electrical stimulation is often used, and in the literature there is evidence of biofeedback therapy efficacy.
Goal of the study is to investigate whether there is a difference in pain reduction, increase in quadriceps muscle strength, and improvement in knee function in patients who had only kinesitherapy, from those who underwent kinesitherapy and biofeedback, and in patients who received electrical stimulation of quadriceps muscle with kinesitherapy. 93 patients with knee OA according to ACR criteria and Kellgren and Lawrence radiological classification grades 1 and 2 will be included in study. Subjects will complete: Visually Analogous Pain Scale (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36), International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set, and quadriceps muscle strength will be measured by EMG biofeedback device.
详细描述
The research will be conducted in the Department of Orthopedic surgery of the Clinical Hospital Center Zagreb. The research will be prospective, randomized, single blinded. Randomization of patients will be performed before physical therapy using web site www.randomization.com, and the results of the randomization will be known to the physician who will not be directly involved in the treatment or examination of patients.
All patients will sign informed consent before the study begins. Research has been approved by the Ethics Committee of Clinical Hospital Center Zagreb and Ethics committee of the School of Medicine, University of Zagreb.
Inclusion criteria are: patients age 55 years and older who have knee OA according to the American College of Rheumatology criteria (ACR) and knee OA according to Kellgren and Lawrence Radiology Classification Grade 1 and 2, and who report knee pain for at least 3 months. Exclusion criteria are: patients who had surgery on that knee, patients with a pacemaker, and metallic foreign body in the area of muscle stimulation, patients with thrombophlebitis and deep vein thrombosis, patients with skin infection, malignancy, bleeding disorders, patients with neurological disease, patients with inflammatory rheumatological disease, with congenital and acquired knee deformities, with contractures of the hips and ankles, with grade 3 and 4 osteoarthritis according to Kellgren and Lawrence classification, patients who received intraarticular knee injection in the last 3 months and patients with post-traumatic knee osteoarthritis and osteonecrosis.
The investigators will record: age, sex, height, weight, body mass index, leg length and use of orthopedics aids. Clinical examination will be performed on the first day, day 21, after 90 and after 180 days.
At each examination patients will complete following questionnaires: Visually Analog Scale for pain (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36) and International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set.
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 (Investigator, Outcomes Assessor)
盲法说明
The research will be single-blind. Randomization of patients will be performed immediately prior to physical therapy using web page www.randomization.com, and the results of the randomization will be known to the physician who will not be directly involved in the treatment or examination of patients.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiological evidence of primary OA with Grade 1 and 2 on the Kellgren-Lawrence Scale
- •knee pain for 3 months
- •knee osteoarthritis defined by American College of Rheumatology Criteria
排除标准
- •surgery on that knee
- •pacemaker
- •metallic foreign body in the area of stimulation
- •thrombophlebitis and thrombosis
- •skin infection
- •malignancy,
- •bleeding disorders
- •neurological disease
- •inflammatory rheumatology disease
- •congenital and acquired knee deformities
- •contracture of the hips and ankles
- •grade 3 and 4 osteoarthritis om the Kellgren and Lawrence classification
- •intraarticular injection in the last 3 months
- •post-traumatic knee osteoarthritis and osteonecrosis
结局指标
主要结局
Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS).
时间窗: 6 months
Determine whether the use of biofeedback for quadriceps muscle strengthening will change knee pain score measured on Visual Analogue Scale (VAS). Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.
次要结局
- Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.(6 months)
- Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).(6 months)
- Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).(6 months)
- Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).(6 months)
- Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).(6 months)
- Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.(6 months)
- Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).(6 months)
- Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.(6 months)
研究者
Silvija Mahnik
MD, Physical medicine and rehabilitation specialist
Clinical Hospital Centre Zagreb