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临床试验/NCT01762358
NCT01762358已完成不适用

Effectiveness of a Non-invasive Therapy for Treating Fully Ruptured Anterior Cruciate Ligaments in the Knee by Using MRI, Functional Tests and Scores: A Randomized Controlled Trial

Medical University of Graz7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
7
主要终点
Knee function

研究概览

简要总结

The primary hypothesis is that Khalifa's therapy brings additional benefit compared to standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament (ACL).

详细描述

Mohamed Khalifa, a therapist from Hallein (Austria), has been working since 30 years with a self-developed manual technique for treating injuries of the musculoskeletal system especially of the knee by applying high pressure to the skin in the area of the injury. This pressure is applied in various amplitudes and frequencies.

International top athletes from various disciplines reported a rapid pain relief, and even full recovery, immediately after his one hour treatment.

Prior to the investigators' study, the investigators evaluated one pilot patient with a complete ACL rupture after a soccer game with Magnet-Resonance-Imaging (MRI) and clinical tests. This patient was physically immobile and reported pain especially when stretching and bending the knee. After one hour of treatment from Khalifa the signs of the injury like the stretching / bending inhibition and pain were gone immediately. Three months after the treatment, an evaluation of the knee with MRI showed an end-to-end continuous ACL with homogeneous signal and the clinical tests confirmed the stability of the knee.

With this study the investigators will evaluate the possibility of influencing the healing of a completely ruptured ACL of the knee by one single special local pressure treatment to the skin for 60 min.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • totally ruptured ACL - MRI verified, 4 weeks old as a maximum
  • knee function: Any functional inhibition (stretching, bending or load)
  • BMI: 18-28
  • athletically active

排除标准

  • any surgical procedures at the injured knee at any previous time
  • any acute surgical indication
  • diabetes mellitus and/or high blood pressure
  • any permanent drug treatment

结局指标

主要结局

Knee function

时间窗: 24 hours and 3 months after 1st therapy

IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation

ACL Morphology

时间窗: 3 months after 1st therapy

Magnet resonance images: end-to-end homogeneous anterior cruciate ligament

次要结局

  • Life Quality(24 hours, 3 months)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Sandner-Kiesling , MD

Univ.Prof.Dr.

Medical University of Graz

研究点 (7)

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