A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Numerical Rating scale (NRS) for pain (0-10)
研究概览
简要总结
This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group.
In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).
详细描述
The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A.
The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of the knee
- •pain intensity > 3 on the numerical rating scale (0-10)
排除标准
- •knee arthroplasty
- •dermal Irritation at the skin of the knee
- •carcinoma
- •known osteoarthritis grade 4 (Kellgren and Lawrence score)
研究组 & 干预措施
First group
control group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10
干预措施: Microcurrent therapy (Device)
Second group
Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10
after washing out control group
干预措施: Microcurrent therapy (Device)
结局指标
主要结局
Numerical Rating scale (NRS) for pain (0-10)
时间窗: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
numerical Rating scale
次要结局
- Short-Form 36(Change of scores: Before treatment vs. end of treatment (in average 21 days later))
- Range of Motion knee joint(Change: Before treatment vs. end of treatment (in average 21 days later))
- Get-up-and-Go-Test (GUG)(Change: Before treatment vs. end of treatment (in average 21 days later))
- Knee injury and Osteoarthritis Outcome Score(Change of scores: Before treatment vs. end of treatment (in average 21 days later)
- Satisfaction with Treatment (Questionnaire)(Evaluation at the end of treatment (in average 21 days after Start of treatment))
- 6-minute walking test(Change: Before treatment vs. end of treatment (in average 21 days later))
研究者
PD Dr. Martin Weigl, MPH
PD, MD, MPH (Harvard University)
Ludwig-Maximilians - University of Munich