Clinical trial NCT01762358: Khalifa Effectiveness Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Rupture of the Anterior Cruciate Ligament in the Knee
Keywords: ACL
Ligament
Knee
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: ACL Morphology
timeFrame: 3 months after 1st therapy
measure: Knee function
timeFrame: 24 hours and 3 months after 1st therapy
Secondary outcomes:
measure: Life Quality
timeFrame: 24 hours, 3 months
Other outcomes:
measure: Confidence
timeFrame: 24 hours, 3 months
Locations:
city: Graz
country: Austria
facility: LKH
city: Graz
country: Austria
facility: UKH
city: Kirchdorf
country: Austria
facility: LKH
city: Linz
country: Austria
facility: AKH
Study officials:
affiliation: UKH Graz
name: Engelbert Wallenböck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AKH Kirchdorf
name: Robert Pehn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LKH Graz
name: Frank Schneider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AKH Linz
name: Andreas Kastner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Med Uni Graz
name: Andreas Sandner, MD
role: STUDY_DIRECTOR
References: