Khalifa Effectiveness Study

Not Applicable

Completed

• Conditions: Total Rupture of the Anterior Cruciate Ligament in the Knee
• Interventions: Other: Physiotherapy; Other: Khalifa's therapy

• Registration Number: NCT01762358
• Lead Sponsor: Medical University of Graz

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2011-05
• Study Completion: 2011-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Physiotherapy	Standardized physiotherapy for 12 times (15 patients)
Standard + Khalifa	Khalifa's therapy	Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Life Quality	24 hours, 3 months	A Visual Analogue Scale was used to evaluate: Pain and Well-being

Trial Locations

Locations (3)

AKH; 🇦🇹 Linz, Austria

UKH; 🇦🇹 Graz, Austria

LKH; 🇦🇹 Kirchdorf, Austria