Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Objective Kinematic Correlates of Palpatory Diagnosis

This study has been completed.
American Osteopathic Association
Information provided by:
Michigan State University Identifier:
First received: July 31, 2008
Last updated: September 17, 2010
Last verified: September 2010

Hypothesis: Kinematic parameters can be used to monitor changes in three-dimensional head movements after Manual Therapy treatments.

Subjects who have some level of cervical dysfunction will be examined by an experienced Osteopathic physician. During the clinical assessment of cervical lateral flexion, kinematic data will be recorded. Subjects will be treated using manual therapy techniques and kinematic data will be recorded again at set intervals after the treatment.

Condition Intervention
Cervical Spine
Procedure: Manual Therapy Techniques

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Objective Kinematic Correlates of Palpatory Diagnosis

Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Three-dimensional kinematics [ Time Frame: Same day, 24 hours, 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Manual Therapy Techniques
    One of the following will be selected(1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method
Detailed Description:

The physician providing treatment will use, depending on his professional judgment for each subject, one of four treatment modalities: (1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method. These modalities are standard to the care and practice of osteopathic manual medicine, they are taught in the Osteopathic curriculum, and they are practiced each day at the Michigan State University Clinical Center.

After the initial treatment, there will be an immediate follow-up kinematic test to collect the 3-D motion data. Then, subjects will return for subsequent kinematic assessments at: 24 hours post treatment, 48 hours post treatment and seven days post treatment. At the seven day mark, subjects will be evaluated as in the initial assessment and the physician will use his professional judgment to determine if the subject would benefit from a second treatment. If so, then the process of treatment and kinematic assessment would occur a second time, with kinematic assessment 24 hours post treatment, 48 hours post treatment and seven days post treatment. A maximum of two treatment sessions will be performed.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and Females over the age of 18 and up to 100 years of age

Exclusion Criteria:

  • Pregnant women and minors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00728247

United States, Michigan
Biomechanical Design Research Laboratory
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
American Osteopathic Association
  More Information

No publications provided

Responsible Party: Tamara Reid Bush and Joseph Vorro, Michigan State University Identifier: NCT00728247     History of Changes
Other Study ID Numbers: Bush-headneck
Study First Received: July 31, 2008
Last Updated: September 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
Cervical Spine
Biomechanics processed this record on March 01, 2015