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).
Total Rupture of the Anterior Cruciate Ligament in the Knee
Other: Khalifa's therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official 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|
- ACL Morphology [ Time Frame: 3 months after 1st therapy ] [ Designated as safety issue: No ]Magnet resonance images: end-to-end homogeneous anterior cruciate ligament
- Knee function [ Time Frame: 24 hours and 3 months after 1st therapy ] [ Designated as safety issue: No ]IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation
- Life Quality [ Time Frame: 24 hours, 3 months ] [ Designated as safety issue: No ]A Visual Analogue Scale was used to evaluate: Pain and Well-being
- Confidence [ Time Frame: 24 hours, 3 months ] [ Designated as safety issue: No ]Confidence in therapists / doctors were evaluated by questionnaire
|Study Start Date:||June 2005|
|Study Completion Date:||October 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Standard Therapy
Standardized physiotherapy for 12 times (15 patients)
Twelve times standardized Physiotherapy
Experimental: Standard + Khalifa
Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients)
Other: Khalifa's therapy
One hour of Khalifa's therapy which is specially applied pressure to the skin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762358
|Graz, Austria, 8020|
|Graz, Austria, 8010|
|Kirchdorf, Austria, 4560|
|Linz, Austria, 4021|
|Principal Investigator:||Engelbert Wallenböck, MD||UKH Graz|
|Principal Investigator:||Robert Pehn, MD||AKH Kirchdorf|
|Principal Investigator:||Frank Schneider, MD||LKH Graz|
|Principal Investigator:||Andreas Kastner, MD||AKH Linz|
|Study Director:||Andreas Sandner, MD||Med Uni Graz|