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Completed

NCT Number: NCT01762358

Khalifa Effectiveness Study

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).

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Key information

Conditions

Total Rupture of the Anterior Cruciate Ligament in the Knee

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Khalifa's therapy

Other

One hour of Khalifa's therapy which is specially applied pressure to the skin

Physiotherapy

Other

Twelve times standardized Physiotherapy

Primary outcomes

  1. ACL Morphology

    Time frame: 3 months after 1st therapy

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

  2. Knee function

    Time frame: 24 hours and 3 months after 1st therapy

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

Secondary outcomes

  1. Life Quality

    Time frame: 24 hours, 3 months

    A Visual Analogue Scale was used to evaluate: Pain and Well-being

Other outcomes

  1. Confidence

    Time frame: 24 hours, 3 months

    Confidence in therapists / doctors were evaluated by questionnaire

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2013
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.