Khalifa Effectiveness Study

Total Rupture of the Anterior Cruciate Ligament in the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762358
• Other study ID #: KhalMUG1
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: January 4, 2013
• Start date: June 2005
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Rupture of the Anterior Cruciate Ligament in the Knee

Intervention

Other:
• Khalifa's therapy
One hour of Khalifa's therapy which is specially applied pressure to the skin
• Physiotherapy
Twelve times standardized Physiotherapy

Locations

Country	Name	City	State
Austria	LKH	Graz
Austria	UKH	Graz
Austria	LKH	Kirchdorf
Austria	AKH	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Confidence	Confidence in therapists / doctors were evaluated by questionnaire	24 hours, 3 months	No
Primary	ACL Morphology	Magnet resonance images: end-to-end homogeneous anterior cruciate ligament	3 months after 1st therapy	No
Primary	Knee function	IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation	24 hours and 3 months after 1st therapy	No
Secondary	Life Quality	A Visual Analogue Scale was used to evaluate: Pain and Well-being	24 hours, 3 months	No