The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale
研究概览
简要总结
It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison with a "sham" diathermy treatment. The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce pain and inflammation and allowing healing processes. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy). Each subject, randomly assigned to either resistive capacitive diathermy treatment (group 1) or sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster Universities Arthritis Index) to assess pain and physical functioning, a visual analogic scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale). Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of 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, Investigator, 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
- •Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views
排除标准
- •Neurologic Disorders involving the lower limbs
- •Systemic inflammatory disorders
- •pace-maker implantation
- •Severe heart disease
- •Acute infections or bone tuberculosis
- •Acute skin diseases
- •History of surgery on the affected knee
- •Cognitive or psychiatric disorders
结局指标
主要结局
changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale
时间窗: baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment
assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs
次要结局
- changing of visual analogic scale (VAS)(baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment)
- MRC scale = Medical Research Council Scale(baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment)
研究者
Carlo Bertolini
Investigator
Catholic University of the Sacred Heart
