Khalifa Effectiveness Study

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

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).

Study Overview

• Status: Completed
• Conditions: Total Rupture of the Anterior Cruciate Ligament in the Knee
• Intervention / Treatment: Other: Physiotherapy; Other: Khalifa's therapy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confidence	Confidence in therapists / doctors were evaluated by questionnaire	24 hours, 3 months

Collaborators and Investigators

• Sponsor: 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; Study Director: Andreas Sandner, MD, Med Uni Graz

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (ESTIMATE): January 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 4, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: ACL; Knee; Ligament
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: KhalMUG1