Algometer and Category II Pelvic Blocking and Cranial Protocol

This study has been completed.

Sponsor:

Information provided by:

Logan College of Chiropractic

ClinicalTrials.gov Identifier:

NCT00649753

First received: March 27, 2008

Last updated: July 22, 2009

Last verified: March 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 27, 2008
Last Updated Date	July 22, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	Algometer readings [ Time Frame: pre and post treatment intervention ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00649753 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	Algometer and Category II Pelvic Blocking and Cranial Protocol
Official Title ^ICMJE	An Investigation of Algometer Readings for DeJarnette Category II Indicators After Category II Blocking and Cranial Protocol
Brief Summary	The purpose of this study is to evaluate the relationship of pelvic blocking and protocol for cranial adjusting with specific pain areas as outlined by Dr. Bertrand DeJarnette in the Category II/sacroiliac protocol. An algometer will be used to determine the level of pain at specific points before and after each treatment of pelvic blocking with or without cranial adjusting.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Pain Sacroiliac Joint Dysfunction
Intervention ^ICMJE	Procedure: Category II Pelvic Blocking Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction. Procedure: Category II Pelvic Blocking and Cranial Supine Orthopedic Blocking consists of placing padded wedges underneath the Ilium and greater trochanter to correct pelvic torsion and associated sacroiliac dysfunction. During pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts. Procedure: Cranial Only Without pelvic blocking a cranial procedure is performed using a zygomae release and sphenobasilar release. These cranial procedures are manual therapy procedures using light pressure from hand and/or finger contacts.
Study Arm (s)	No Intervention: A Experimental: B Intervention: Procedure: Category II Pelvic Blocking Experimental: C Intervention: Procedure: Category II Pelvic Blocking and Cranial Experimental: D Intervention: Procedure: Cranial Only
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
Estimated Enrollment ^ICMJE	40
Completion Date	August 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Logan student, staff or faculty Age 18 - 60 No chiropractic adjustment 2 weeks prior to beginning the study Show the DeJarnette Category II indicators Exclusion Criteria: Previous lower extremity, first rib and spine injury, surgery Local infection, injury or other malignancy affecting the lower extremity and the nervous system Unstable joints of the lower extremity and/or first rib and/or spine Prescription or herbal muscle stimulants, relaxants, etc. that could affect the nervous system Contraindication to DeJarnette Category II Pelvis Blocking Pregnancy Significant lower lumbar involvement Diabetes, shortness of breath on light physical activity, cardiovascular disease Numbness and/or tingling in the lower extremities
Gender	Both
Ages	18 Years to 60 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	NCT00649753
Other Study ID Numbers ^ICMJE	SR0225080125
Has Data Monitoring Committee	Not Provided
Responsible Party	Mary Unger-Boyd, D.C., Logan College
Study Sponsor ^ICMJE	Logan College of Chiropractic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Logan College of Chiropractic
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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