Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Khalifa Effectiveness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01762358
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Total Rupture of the Anterior Cruciate Ligament in the Knee Other: Khalifa's therapy Other: Physiotherapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  2. 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 :
  1. Life Quality [ Time Frame: 24 hours, 3 months ]
    A Visual Analogue Scale was used to evaluate: Pain and Well-being


Other Outcome Measures:
  1. Confidence [ Time Frame: 24 hours, 3 months ]
    Confidence in therapists / doctors were evaluated by questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762358


Locations
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Andreas Sandner-Kiesling , MD, Univ.Prof.Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01762358    
Other Study ID Numbers: KhalMUG1
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Keywords provided by Andreas Sandner-Kiesling , MD, Medical University of Graz:
ACL
Ligament
Knee
Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Wounds and Injuries