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临床试验/NCT01938131
NCT01938131已完成不适用

Effectiveness of Treatment With rMV (Repeated Muscle Vibration) in Patients Affected by Knee Osteoarthritis: a Prospective Randomized Clinical Trial

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 in patients' ability (as measured by WOMAC scale)

研究概览

简要总结

The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in elderly patients because they are long lasting and need the constant participation of patients. To rapidly improve the motor performances of patients it is possible to use the mechanical vibration applied to individual muscles using a protocol called "repeated muscle vibration" (rMV). The purpose of this single-blind randomized placebo-controlled study is to evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the ability of the patients affected by knee osteoarthritis, compared to an ineffective treatment, considered as a placebo. Each subject, randomly assigned to either the group 1 (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications it's observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed near the supero-medial margin of the patella, on both quadriceps. Patients in group 2 (control group) are subjected to a treatment with muscle released in which the probe of the same instrument is approached to the quadriceps, without making contact. The instrument in these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the study is to determine the changing in patients' ability (as measured by WOMAC scale = Western Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of the study are the assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale) and assessment of changing of patients' quality of life (as measured by EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment and 6 months (T4) after the end of the 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

  • Knee Osteoarthritis

排除标准

  • Neurologic disease involving the lower limbs or causing balance problems
  • Systemic inflammatory diseases
  • Diabetic Neuropathy
  • Severe heart disease.
  • Acute infections or bone Tuberculosis
  • Prosthetic lower limbs
  • History of surgery on the affected knee in the last year
  • History of cancer
  • Cognitive impairment

结局指标

主要结局

changing in patients' ability (as measured by WOMAC scale)

时间窗: baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment

administration of WOMAC scale for patient's ability evaluation

次要结局

  • assessment of changing of patients' balance and risk of falling (as measured by the Tinetti scale)(baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment)
  • assessment of changing of patients' quality of life (as measured by EQ-VAS)(baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of treatment, 6 months (T4) after the end of the treatment)

研究者

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

Carlo Bertolini

Principal Investigator

Catholic University of the Sacred Heart

研究点 (1)

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