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临床试验/NCT01800955
NCT01800955已完成不适用

The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Bertolini

Investigator

Catholic University of the Sacred Heart

研究点 (1)

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