Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- WOMAC - Pain
研究概览
简要总结
Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.
详细描述
120 patients with indications for surgical knee treatment from IOT-HCFMUSP will be invited to participate in the project. Inclusion applications and those who agree to sign a free and informed consent form (IC) will be included.
During the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. Then, the included patients are randomized into four existing groups:
Group A - Acupuncture Sham + Cupping Sham; Group B - Sham Acupuncture + Real Cupping; Group C - Real Acupuncture + Sham Cupping; Group D - Real Acupuncture + Real Cupping.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of knee osteoarthritis
- •WOMAC-Pain greater than or equal to 15 points.
排除标准
- •advanced degenerative central neuropathy (Parkinson's, Alzheimer's)
- •diabetic peripheral neuropathy
- •stroke sequela
- •history of digestive bleeding
- •chronic renal failure
- •renal failure
- •heart failure
- •fibromyalgia
- •rheumatoid arthritis
- •severe depression
- •psychiatric disorders
- •concomitance with hip arthritis
结局指标
主要结局
WOMAC - Pain
时间窗: value collected at 5 week
Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
VAS
时间窗: Value collected at 5 weeks
Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)
次要结局
- Analgesic Consumption(Number of Participants with reduction in the use of pain medications after protocol (at 5 week))