Khalifa Effectiveness Study - Full Text View

Purpose

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).

Condition	Intervention
Total Rupture of the Anterior Cruciate Ligament in the Knee	Other: Khalifa's therapy Other: Physiotherapy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (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

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U.S. FDA Resources

Further study details as provided by Andreas Sandner-Kiesling , MD, Medical University of Graz:

Primary Outcome Measures:

ACL Morphology [ Time Frame: 3 months after 1st therapy ]
Magnet resonance images: end-to-end homogeneous anterior cruciate ligament
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 Outcome Measures:

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

Other Outcome Measures:

Confidence [ Time Frame: 24 hours, 3 months ]
Confidence in therapists / doctors were evaluated by questionnaire


Enrollment:	30
Study Start Date:	June 2005
Study Completion Date:	October 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard Therapy Standardized physiotherapy for 12 times (15 patients)	Other: Physiotherapy 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

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762358

Locations


Austria
LKH
Graz, Austria, 8010
UKH
Graz, Austria, 8020
LKH
Kirchdorf, Austria, 4560
AKH
Linz, Austria, 4021

Sponsors and Collaborators

Medical University of Graz

Investigators


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

More Information


Responsible Party:	Andreas Sandner-Kiesling , MD, Univ.Prof.Dr., Medical University of Graz
ClinicalTrials.gov Identifier:	NCT01762358 History of Changes
Other Study ID Numbers:	KhalMUG1
Study First Received:	January 4, 2013
Last Updated:	January 4, 2013

Keywords provided by Andreas Sandner-Kiesling , MD, Medical University of Graz:


ACL Ligament Knee

Additional relevant MeSH terms:


Rupture Wounds and Injuries

ClinicalTrials.gov processed this record on September 21, 2017