Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dennis Enix, DC, MBA, Logan College of Chiropractic

ClinicalTrials.gov Identifier:

NCT00620906

First received: February 12, 2008

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 12, 2008
Last Updated Date	May 1, 2013
Start Date ^ICMJE	January 2007
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 21, 2008)	Sacroiliac joint motion was assessed with the Polhemus Liberty motion capture system. [ Time Frame: Pre and Post therapy ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00620906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation
Official Title ^ICMJE	Motion Capture Analysis of Sacroiliac Joint Motion After Manipulation
Brief Summary	The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system.
Detailed Description	The Sacroiliac (SI) joint is a diarthrodial joint with the contradictory biomechanical function of transmitting compressive loads from the lumbar spine to the lower extremity while maintaining a nutating motion in the pelvis. Recent studies identify the Sacroiliac (SI) joints as a significant source of pain in patients with chronic low back pain, contributing up to 27%. Recent studies have demonstrated that historical and physical examination findings and radiological imaging alone are insufficient to diagnose SI joint pain. The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system. The Absolute angular deviation of sacroiliac joint motion will be assessed during the normal gait cycle with the Polhemus Liberty motion capture system. Six sensors will be attached to specific anatomical landmarks of the pelvis which recorded motion characteristics while walking on a treadmill at 5 mph. The subjects then receive a HVLA manipulation to the SI joint and were retested at the same treadmill speed. The Motion capture system tracks objects at a speed of 240 updates per second on all sensors simultaneously. The latency of data sampling is less than 4ms; 240 x 60 sec x 8 Sensors totaling 115,200 data points per minute. The system generates and tracks electromagnetic fields (EMF), computes position and orientation of sensors in an X, Y, and Z coordinate system while interfacing with a computer. The EMF source contains electromagnetic coils that emit a magnetic field. The source is the system's reference frame for sensor measurements. The sensor contains electromagnetic coils (accelerometers) that detect the position and orientation of the magnetic fields emitted by the EMF source.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Sacroiliac Joint Pain
Intervention ^ICMJE	Procedure: Manipulation HVLA manipulation to Sacroiliac Joint
Study Arm (s)	A Manipulation Intervention: Procedure: Manipulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	March 2008
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Ages between 20 and 40 Ability to maintain normal balance Willingness to undergo HVLA manipulation to the SI Joints Normal blood pressure Exclusion Criteria: Any visual or vestibular condition or systemic illness that would affect balance Any recent surgery, unstable joints of the lower extremity, recent hip and knee joint replacements or fitted hip or knee pins, bolts and/or plates Currently have any infection, acute inflammation, recent wounds, injury, tumors or other malignancy Currently taking any medications; prescription or herbal muscle stimulants, relaxants, etc. A history of acute disc herniation, discopathy or spondylolysis A history of acute thrombosis, serious cardiovascular disease, diabetes, have irregular heartbeats(arrhythmia) or wear a pacemaker Any implanted device or prosthesis type of device Any Spinal manipulation within 48 hours Ages under 20 and over 40 Estimated BMI greater than 30
Gender	Both
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00620906
Other Study ID Numbers ^ICMJE	RD0524070094
Has Data Monitoring Committee	No
Responsible Party	Dennis Enix, DC, MBA, Logan College of Chiropractic
Study Sponsor ^ICMJE	Logan College of Chiropractic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Logan College of Chiropractic
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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