Total Rupture of the Anterior Cruciate Ligament in the KneeNCT01762358
Khalifa Effectiveness Study
A study testing Khalifa's therapy and Physiotherapy in people with Total Rupture of the Anterior Cruciate Ligament in the Knee, run by Medical University of Graz at 4 sites in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Total Rupture of the Anterior Cruciate Ligament in the Knee
- What is being tested?
- Khalifa's therapy and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesAustria
- Study dates
- Jun 2005to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
About this 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
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).
Read the 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.
- Being tested
- Khalifa's therapy, Physiotherapy
- Keywords
- ACL, Ligament, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khalifa's therapyOther
One hour of Khalifa's therapy which is specially applied pressure to the skin
PhysiotherapyOther
Twelve times standardized Physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Standardized physiotherapy for 12 times (15 patients) Receives: Other: Physiotherapy |
| Standard + Khalifa | Experimental | Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients) Receives: Other: Khalifa's therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACL Morphology
Magnet resonance images: end-to-end homogeneous anterior cruciate ligament
Measured: 3 months after 1st therapy
Knee function
IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation
Measured: 24 hours and 3 months after 1st therapy
Secondary outcomes (1)
Life Quality
A Visual Analogue Scale was used to evaluate: Pain and Well-being
Measured: 24 hours, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJun 2005
- Primary completionMay 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Rupture of the Anterior Cruciate Ligament in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Sandner-Kiesling , MD, Medical University of Graz
- Investigators
- Engelbert Wallenböck, MD, Principal investigator, UKH GrazRobert Pehn, MD, Principal investigator, AKH KirchdorfFrank Schneider, MD, Principal investigator, LKH GrazAndreas Kastner, MD, Principal investigator, AKH LinzAndreas Sandner, MD, Study director, Med Uni Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762358
- Sponsor's protocol ID
- KhalMUG1
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2013
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01762358
- Acronym / sponsor ID
- KhalMUG1
- Keywords
- ACL, Ligament, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Other: PhysiotherapyStandardized physiotherapy for 12 times (15 patients) |
| Standard + Khalifa | Experimental | Other: Khalifa's therapyInitial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khalifa's therapyOne hour of Khalifa's therapy which is specially applied pressure to the skin | Other | Standard + Khalifa |
| PhysiotherapyTwelve times standardized Physiotherapy | Other | Standard Therapy |
Primary outcome
ACL Morphology
Time frame: 3 months after 1st therapy
Magnet resonance images: end-to-end homogeneous anterior cruciate ligament
Knee function
Time frame: 24 hours and 3 months after 1st therapy
IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation
1 secondary outcome
Life Quality
Time frame: 24 hours, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engelbert Wallenböck, MD principal investigator
UKH Graz
Robert Pehn, MD principal investigator
AKH Kirchdorf
Frank Schneider, MD principal investigator
LKH Graz
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khalifa's therapy and Physiotherapy in people with Total Rupture of the Anterior Cruciate Ligament in the Knee, run by Medical University of Graz at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACL Morphology (time frame: 3 months after 1st therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.