Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
研究概览
简要总结
This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.
详细描述
This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis.
- •Age over 40 years old.
排除标准
- •Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis.
- •Sprain or trauma in the lower limb.
- •Mental disorders.
- •Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease.
- •Pregnancy or lactation.
- •Use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.
研究组 & 干预措施
Real Acupuncture
Acupuncture at nine acupoints. Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks
干预措施: Real Acupuncture (Other)
Non-acupuncture at real-acupoint
The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group.
干预措施: Non-acupuncture at real-acupoint (Other)
Shallow acupuncture at real-acupoint
At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
干预措施: Shallow acupuncture at real-acupoint (Other)
Shallow acupuncture at non-meridian and non-acupoint
At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
干预措施: Shallow acupuncture at non-meridian and non-acupoint (Other)
Waiting-list group
No acupuncture treatment will be given during the study period.
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
时间窗: 2 week
The WOMAC, a disease-specific scale with high reliability and validity, has been translated into different languages and used widely in clinical trials for KOA. The Chinese version of WOMAC contains 24 items that measure pain (5 items, scored 0-50), stiffness (2 items, scored 0-20) and physical function (17 items, scored 0-170), with a total score ranging from 0 to 240
次要结局
- Visual analogue scale (VAS)(2 week)
- Blind Assessment Scale(2 week)
- Massachusetts General Hospital Acupuncture Sensation Scale (MASS)(2 week)