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Khalifa Effectiveness Study

Primary Purpose

Total Rupture of the Anterior Cruciate Ligament in the Knee

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Khalifa's therapy

Physiotherapy

About this trial

This is an interventional treatment trial for Total Rupture of the Anterior Cruciate Ligament in the Knee focused on measuring ACL, Ligament, Knee

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

Standard + Khalifa

Arm Description

Standardized physiotherapy for 12 times (15 patients)

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

Outcomes

Primary Outcome Measures

ACL Morphology

Magnet resonance images: end-to-end homogeneous anterior cruciate ligament

Knee function

IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation

Secondary Outcome Measures

Life Quality

A Visual Analogue Scale was used to evaluate: Pain and Well-being

Full Information

NCT ID

NCT01762358

First Posted

January 4, 2013

Last Updated

January 4, 2013

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT01762358

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Graz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Rupture of the Anterior Cruciate Ligament in the Knee

Keywords

ACL, Ligament, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Therapy

Arm Type

Active Comparator

Arm Description

Standardized physiotherapy for 12 times (15 patients)

Arm Title

Standard + Khalifa

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Khalifa's therapy

Intervention Description

One hour of Khalifa's therapy which is specially applied pressure to the skin

Intervention Type

Other

Intervention Name(s)

Physiotherapy

Intervention Description

Twelve times standardized Physiotherapy

Primary Outcome Measure Information:

Title

ACL Morphology

Description

Magnet resonance images: end-to-end homogeneous anterior cruciate ligament

Time Frame

3 months after 1st therapy

Title

Knee function

Description

IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation

Time Frame

24 hours and 3 months after 1st therapy

Secondary Outcome Measure Information:

Title

Life Quality

Description

A Visual Analogue Scale was used to evaluate: Pain and Well-being

Time Frame

24 hours, 3 months

Other Pre-specified Outcome Measures:

Title

Confidence

Description

Confidence in therapists / doctors were evaluated by questionnaire

Time Frame

24 hours, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials: