The Comparison of the Effectiveness of Exercise and Topical Agent Treatments in Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change of Pain via Numeric Pain Rating Scale
研究概览
简要总结
Osteoarthritis, a chronic and degenerative joint disease, is the most common type of arthritis and affects more than 300 million adults worldwide. Osteoarthritis, which is characterized by joint pain and stiffness, has negative consequences for function, participation and quality of life, which are important components of health. The knee joint is the most common joint in terms of osteoarthritis and is more common in individuals over 50 years of age.
There is no proven definitive treatment in today's literature for common osteoarthritis, which is one of the important causes of the global disease burden. However, since it is a progressive disease with varying degrees of severity, it is a chronic problem that requires long-term treatment. According to current clinical guidelines prepared by the working groups of the International Osteoarthritis Research Society (OARSI) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases ESCEO , treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids; In more severe cases, joint replacement surgery is recommended.
The aim of this research project is to examine the effectiveness of a supervised exercise program applied in combination with NSAID-specific topical agents, in comparison with groups receiving only topical agents or only exercise treatments.
详细描述
Voluntary participants who have been diagnosed with knee osteoarthritis will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into tree groups. Study groups will be as follows: a) exercise, b) exercise & topical agent, c) topical agent.
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 (Investigator)
盲法说明
The assessor will not know which participant received which intervention.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with knee OA according to the criteria of the American Society of Rheumatology
- •Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- •Those between the ages of 40 and 65
- •Body mass index below 30 kg/m2
- •Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS
- •Patients who do not have any obstacles to be included in the exercise program
排除标准
- •Using viscosupplementation or steroid injection or systemic steroids in the related knee in the last 3 months
- •To have received a physiotherapy program for the relevant knee in the last 3 months
- •Having a valgus or varus deformity greater than 15°
- •Presence of active infection or tumor
- •Presence of neurological diseases and/or deformity leading to lower extremity muscle weakness
- •Having serious systemic and cardiovascular diseases that interfere with exercise
结局指标
主要结局
Change of Pain via Numeric Pain Rating Scale
时间窗: change from baseline pain at 6 months
On this scale, "0" indicates the absence of pain, and "10" indicates the most severe pain imaginable (17). Patients will be asked to rate the severity of their knee pain with a number between 0 and 10 using this scale. The minimum clinically significant difference value (MCID) of this valid and reliable pain scale is 1.74 points.
次要结局
- WOMAC(4 times for 24 weeks)
- 40 meters fast walking test(4 times for 24 weeks)
- Global Rating of Change Scale-GRC(3 times for 24 weeks)
- Joint Range of Motion Evaluation(4 times for 24 weeks)
- Health-Related Quality of Life Short Form (SF-12) Scale(4 times for 24 weeks)
- Stepping Test(4 times for 24 weeks)
研究者
Sezen Karaborklu Argut
Principal Investigator
Istanbul University - Cerrahpasa