Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
研究概览
简要总结
The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.
详细描述
Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. Acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. The improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals.
In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on eating pattern, physical activity and signs of pain last for several years. It may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation.
The purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with OA.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Clinically diagnosed and radiologically verified knee osteoarthritis (OA)
- •Pain and stiffness derived from OA lasting for more than one year
排除标准
- •Previous knee trauma (OA following previous meniscectomy is included)
- •Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia
- •Pronounced hip OA
- •Severe somatic or mental illnesses
- •Alcohol or drug abuse
- •Pregnancy
- •Anticoagulant treatment
- •Corticosteroid treatment during the last 3 months
- •Allergy to chlorhexidine or local anaesthetics
结局指标
主要结局
Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
时间窗: 0, 1, 3, 6, 9, and 12 months
Stiffness is evaluated with the WOMAC questionnaire.
时间窗: 0, 1, 3, 6, 9, and 12 months
Function is evaluated with the WOMAC questionnaire.
时间窗: 0, 1, 3, 6, 9, and 12 months
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
时间窗: 0, 6, and 12 months
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.
时间窗: 0, 6, and 12 months
次要结局
- The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.(2 months before randomisation)
- Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.(The entire study period)
- The time from implantation until the effect possibly sets in.(The entire study period)