A Randomized Prospective Study to Evaluate the Effect of Semiconductor Knee Sleeves on Pain in Osteoarthritis of the Knee.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Knee Pain
研究概览
简要总结
To assess the benefits of using semiconductor (germanium and carbon) woven knee sleeves products in patients with osteoarthritis of the knee. To compare patients in a blinded randomized trial with and without the semiconductor knee sleeves product during the first 3 months period after initial contact at the outpatient clinic.
Aims:
The hypothesis of the study is that the semiconductor sleeve will reduce pain and improve knee function in active group when compared to the placebo group.
详细描述
Semiconductor woven knee sleeves work by increasing circulation to reduce inflammation, relieve pain, optimize performance, and accelerate recovery. Unlike compression products, semiconductor knee sleeves do not need to compress to work. Instead, the technology incorporates the semiconductor elements germanium and carbon within the fabric, which when stimulated by body heat, by release of negative ions. The negative ions activate molecular vibrations that increase blood flow and speed. Increasing circulation helps bring more oxygen and nutrients to the target area, which optimizes the body's natural healing process and accelerates recovery. Benefits of Increased Blood Circulation Include:
- Accelerated Recovery
- Reduced Swelling
- Optimized Performance
- Reduced Fatigue
- Thermoregulation
Investigators wish to investigate a possible effect on knee pain and function in patients with osteoarthritis of the knee.
Subject Enrollment:
Subjects referred with arthrosis of the knee to the out-patient clinic, at the Hip- and Knee-arthroplasty Unit, Herlev Gentofte Hospital. Included subjects must be assessed by an arthroplasty surgeon to have arthrosis without present indication for surgery, and to be eligible for a period of conservative treatment including physiotherapist guided training and paracetamol treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Investigated knee sleeves appear identical, a printed code reveals to investigator if knee sleeves contains semiconductors (intervention group) or are cotton only (placebo group).
Participants, care provider and outcome assessors are blinded to intervention/placebo grouping.
入排标准
- 年龄范围
- — 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthrosis of the Knee
- •Surgery not yet indicated
- •40-90 years old
- •Male or female
- •Compliant patient
- •BMI less than 35
- •Able to understand Danish sufficiently for written consent
排除标准
- •Rheumatoid Arthritis
- •Previous blood clots
- •BMI greater than 35
- •Varicosities on operative leg
结局指标
主要结局
Knee Pain
时间窗: 3 months
Visual Analog Scale 0-100, 0-no pain, 100 maximum pain
次要结局
- Knee Range of Motion (ROM)(3 months)
- Life Quality assessment(3 months)
- Knee function(3 months)
研究者
Mikkel Rathsach Andersen
MD., Ph.D., Associate prof.
Herlev and Gentofte Hospital
