Khalifa Acute Effects

Totally Ruptured Anterior Cruciate Ligament in the Knee Clinical Trial

Official title:

Interdisciplinary Evaluation of Acute Effects From Khalifa's Therapy at Patients With Fully Ruptured Anterior Cruciate Ligament (ACL).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762371
• Other study ID #: KhalSbg1
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: May 4, 2015
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The primary hypothesis is that Khalifa's therapy has different acute effects in various organ systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects might indicate the pathway of the therapy.

Description:

According to our previous study that evaluated the efficacy of Khalifa's therapy the investigators have seen that the therapy has acute effects which resulted in better knee function and later even in better healing of the ACL injury. This study should clear exactly which effects and pathways are involved in the therapy from multiple (interdisciplinary) point of views. Therefore the investigators will measure parameters that might be associated with this special technique directly before and after the therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• totally ruptured ACL - MRI verified, 2 weeks old as a maximum

• knee function: Any functional inhibition (stretching, bending or load)

• BMI: 18-25

• 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Rupture
• Totally Ruptured Anterior Cruciate Ligament in the Knee

Intervention

Other:
• Khalifa Therapy
One hour of Khalifa's therapy which is specially applied pressure to the skin.

Locations

Country	Name	City	State
Austria	Sports Center of University Salzburg	Hallein	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laser Doppler-Flow	Perfusion	1 hour	No
Primary	NIRS	Near infrared spectroscopy, Oxygen saturation	1 hour	No
Primary	IR Thermography	Infrared thermography, temperature	1 hour	No
Primary	QST	Quantitative sensoric testing, pain	1 hour	No
Primary	HRV	Heart rate variability, sympathicus/parasympathicus activation	1 hour	No
Primary	EEG	Electroencephalogram, brain waves	1 hour	No
Primary	Knee function	IKDC Score KT-1000 test Clinical / physical examination	1 hour	No
Primary	SportsScience	Posturomed Motion capture proprioception muscle power range of motion	2 hours	No
Primary	Blood	Catecholamines endorphins standard blood parameters	1 hour	No
Secondary	Questionnaire	Different questions about pain, lifestyle, subjective parameters	1 hour	No