Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Numerical Ratings scale (NRS) for pain (0-10)
研究概览
简要总结
This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.
详细描述
The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.
Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.
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)
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
Microcurrent therapy, type A
Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10.
Previous treatments will be continued.
干预措施: Microcurrent therapy (Device)
Microcurrent therapy, type B
Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
干预措施: Microcurrent therapy (Device)
Sham Microcurrent therapy
Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
干预措施: Microcurrent therapy (Device)
No Intervention
No Intervention. Previous treatments will be continued.
结局指标
主要结局
Numerical Ratings 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
- 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))
- 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))
- 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