Khalifa Effectiveness Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Total Rupture of the Anterior Cruciate Ligament in the Knee

Intervention / Treatment
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* Other: Khalifa's therapy
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Standardized physiotherapy for 12 times (15 patients) | Other: Physiotherapy<br>* Twelve times standardized Physiotherapy<br>|
| Experimental: Standard + Khalifa<br>Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients) | Other: Khalifa's therapy<br>* One hour of Khalifa's therapy which is specially applied pressure to the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACL Morphology | Magnet resonance images: end-to-end homogeneous anterior cruciate ligament | 3 months after 1st therapy | 
| Knee function | IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation | 24 hours and 3 months after 1st therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Quality | A Visual Analogue Scale was used to evaluate: Pain and Well-being | 24 hours, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Ligament, Knee