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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00620906
Other study ID # RD0524070094
Secondary ID
Status Completed
Phase N/A
First received February 12, 2008
Last updated May 1, 2013
Start date January 2007
Est. completion date March 2008

Study information

Verified date May 2013
Source Logan College of Chiropractic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of manipulation on sacroiliac joint motion using a Polhemus motion capture system.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Manipulation
HVLA manipulation to Sacroiliac Joint

Locations

Country Name City State
United States Logan College of Chiropractic Chesterfield Missouri

Sponsors (1)

Lead Sponsor Collaborator
Logan College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sacroiliac joint motion was assessed with the Polhemus Liberty motion capture system. Pre and Post therapy No
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