Khalifa Effectiveness Study

Medical University of Graz

Status: Completed

Conditions: Total Rupture of the Anterior Cruciate Ligament in the Knee

Treatments: Other: Physiotherapy; Other: Khalifa's therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01762358

KhalMUG1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

Standardized physiotherapy for 12 times (15 patients)

Treatment:

Other: Physiotherapy

Standard + Khalifa

Experimental group

Description:

Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients)

Treatment:

Other: Khalifa's therapy