Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
研究概览
简要总结
The purpose was to assess knee function outcomes between physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up.
详细描述
Metabolic syndrome were diagnosed with abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure and widely prevalence all around the world.MetS patients were always correlated with knee osteoarthritis or cartilage volume loss. For MetS patients with DMLs, whether physical therapy was non-inferior to APM in knee function and MetS components was unknown.
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)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be age between 35 and 70 years old;
- •Clinical diagnosis of metabolic syndrome;
- •Clinical diagnosis of degenerative meniscus lesions;
- •Patients who has knee pain history
- •Knee symptoms consistent with DMLs verified on MRI
- •eligible for arthroscopic partial meniscectomy surgery by the examining orthopedic surgeons.
排除标准
- •Must be able to have no acute knee injury such as car crash or acute sports injury;
- •Must be able to have no knee surgeries history;
- •Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- •Must be able to have no contraindications to MRI;
- •Must be able to have no severe cardiopulmonary disease;
- •Must be able to have no musculoskeletal or neuromuscular impairments ;
- •Must be able to have good visual, hearing, or cognitive;
结局指标
主要结局
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
时间窗: change from baseline up to 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
systolic blood pressure change
时间窗: change from baseline up to 12 months
systolic blood pressure /mmHg
Kellgren-Lawrence (K/L) grade change
时间窗: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade
high-density lipoprotein cholesterol (HDL-C) change
时间窗: change from baseline up to 12 months
serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
fast blood glucose(FBG) change
时间窗: change from baseline up to 12 months
serum fast blood glucose(FBG) (mmol/L)
serum triglycerides (TG) change
时间窗: change from baseline up to 12 months
serum triglycerides (TG) (mmol/L)
low-density lipoprotein cholesterol (LDL-C) change
时间窗: change from baseline up to 12 months
serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
时间窗: change from baseline up to 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
waist circumstance change
时间窗: change from baseline up to 12 months
waist circumstance (cm)
diastolic blood pressure change
时间窗: change from baseline up to 12 months
diastolic blood pressure/mmHg
serum total cholesterol (TC) change
时间窗: change from baseline up to 12 months
serum total cholesterol (TC) (mmol/L)
Body mass index change
时间窗: change from baseline up to 12 months
Body mass index(BMI) weight/height square (kg/㎡)
次要结局
- activities of daily living score change(change from baseline up to 12 months)
- pain score change(change from baseline up to 12 months)
- knee related quality of life score change(change from baseline up to 12 months)
- symptoms score change(change from baseline up to 12 months)
- function in sport and recreation score change(change from baseline up to 12 months)