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Khalifa Effectiveness Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Sandner-Kiesling , MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01762358
First received: January 4, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Tears
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Confidence [ Time Frame: 24 hours, 3 months ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
ACL
Ligament
Knee

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 23, 2016