Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Knee Range of Motion
研究概览
简要总结
Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment.
It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed.
Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
- •Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- •Participants with age between 50 and 70 years old
- •Being able to walk without using an assistive device
- •Having a body mass index of less than 30 kg/m²
- •Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale
排除标准
- •Patients who received physical therapy or intra-articular injections in the last 6 months
- •Receiving an indication for surgery
- •Have severe hearing, vision and speech impairment
- •Having serious systemic and cardiovascular diseases that interfere with exercise
- •Having a lower extremity deformity
- •Patients with acute inflammation of the knee
研究组 & 干预措施
Exercise
All patients will receive an exercise rehabilitation program tailored to their needs.
干预措施: Exercise (Other)
结局指标
主要结局
Knee Range of Motion
时间窗: Baseline, after 15 session and 4 months follow up
Range of motion assessment with goniometer
WOMAC
时间窗: Baseline, after 15 session and 4 months follow up
Western Ontario and McMaster Universities Osteoarthritis Index
LEFS
时间窗: Baseline, after 15 session and 4 months follow up
Lower Extremity Functional Scale
KOOS
时间窗: Baseline, after 15 session and 4 months follow up
Knee Injury and Osteoarthritis Outcome Score
次要结局
- 30s sit to stand test(Baseline, after 15 session and 4 months follow up)
研究者
Derya Celik
Professor
Istanbul University