The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
研究概览
简要总结
Osteoarthritis is the most common chronic disabling disease,the importance of patient's self-management in chronic disease has been paid more and more attention internationally. Currently, the self-management of OA patients in China is lack of instructions from professional clinicians, and leads to inappropriate excise, irregular drug medication. OAKP (Osteoarthritis of the Knee Self-Management Program) is a program initiated from University of Southern Denmark, follows clinical guidelines of OA, formatted for easy use by patients and clinicians, including customized neuromuscular exercise therapy, educational sessions of what is OA and how to control body weight to protect the knee.
The main purpose of this study is to verify the effectiveness of neuromuscular exercise therapy and OAKP, see whether it can help patients to relief the symptom and improve life quality.
详细描述
The study plans to enroll patients above 50 years old who suffered from knee OA, but patients meets any of the exclusion criteria will not be enrolled. 400 patients of knee OA will be randomly divided into A, B, C, D four parallel groups with fully informed, each group will enroll 100 patients, A for control group, B for neuromuscular exercise, C for self-management program, D for neuromuscular exercise and self-management program, respectively. Each collaborate hospital would enroll patients as a multicenter clinical trial. Patient will receive a baseline and 3m, 6m, 12m follow-up evaluation of their knee physical function. Primary outcome measure is KOOS (Knee Injury and Osteoarthritis Outcome Score), secondary evaluation include VAS, EQ-5D, Arthritis self-efficacy score, 6-minutes Walk test, TUG test, 20 meters quick walk test,Stand up test in 30 seconds, Balance test, Kellgren& Lawrence（KL）, Pain medication. Outcome will compare the mean difference between baseline survey and 12 months of follow-up in each group, using t-test or chi-square test,respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessor will not know which group the patients are enrolled when evaluate the baseline and follow-up situation
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:
- •Repeated knee joint pain within 1 month;
- •X-ray(weight-bearing or not)shows narrowed joint space,sclerosis and (or) cystic degeneration of subchondral bone, osteophytes of the joints;
- •The joint fluid (at least twice) is clear and viscous, WBC<2000 个/ml;
- •Age of patients ≥40 yrs;
- •Morning stiffness≤3 min;
- •Bone friction in the activity; Note：Combine clinical feature, laboratory and X-ray examination,when the patients meet(1)+(2) or (1)+(3)+(5)+(6) or (1)+(4)+(5)+(6)，they can be diagnosis as knee osteoarthritis.
- •2.VAS≥4 分; 3.No surgical treatment is planned within 6 months;
排除标准
- •Other types of arthritis, such us RA(rheumatoid arthritis)
- •Severe deformity of knee joint;
- •Over obesity patients（BMI>35）;
- •Other comorbidities that would severely affect somatic function, such as: cerebral infarction, lumbar disease that meets surgical indications, lower extremity angiopathy;
- •Decompensated cardiac dysfunction;
- •Severe cardiovascular and cerebrovascular diseases, or the patient is too weak for any kinds of exercise;
- •Lack of compliance;
研究组 & 干预措施
Control
The patients in this group will only receive health education intervention.
干预措施: Health education (Behavioral)
Neuromuscular exercise therapy
The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
干预措施: Neuromuscular exercise therapy (Behavioral)
Neuromuscular exercise therapy
The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
干预措施: Health education (Behavioral)
Self-management program
The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
干预措施: Self-management program (Behavioral)
Self-management program
The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
干预措施: Health education (Behavioral)
Exercise therapy+self-management
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
干预措施: Self-management program (Behavioral)
Exercise therapy+self-management
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
干预措施: Neuromuscular exercise therapy (Behavioral)
Exercise therapy+self-management
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
干预措施: Health education (Behavioral)
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
时间窗: Baseline, 3 months, 6 months, 12months
WOMAC grade is a reliable knee osteoarthritis patients' self-reported therapeutic effect evaluation system, including three dimensions: pain, stiffness, daily activities and quality of life, and each dimension includes several questions scale from 0(worst) to 4(best) , total score of each dimension range from zero (worst) to 100 (best). Score of each question add together will be the total score. Baseline, 3 months, 6 months, 12 months, through visit or telephone follow-up will be recorded. Compare the mean difference of WOMAC grade between baseline survey and 12 months of follow-up in each group.
次要结局
- EuroQol Five Dimensions Questionnaire（EQ-5D）(Baseline, 3 months, 6 months, 12months)
- Visual Analog Score（VAS）(Baseline, 3 months, 6 months, 12months)
- Kellgren& Lawrence（KL）(Baseline)
研究者
Lin Jianhao
Clinical Research Center of Osteoarthritis
Peking University People's Hospital