Expired Study
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East Lansing, Michigan 48824


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Males and Females over the age of 18 and up to 100 years of age Exclusion Criteria: - Pregnant women and minors


Study is Available At:


Original ID:

Bush-headneck


NCT ID:

NCT00728247


Secondary ID:


Study Acronym:


Brief Title:

Objective Kinematic Correlates of Palpatory Diagnosis


Official Title:

Objective Kinematic Correlates of Palpatory Diagnosis


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Michigan State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Study Dates

Start Date:July 2008
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 17, 2010
First Received Date:July 31, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Three-dimensional kinematics
Time Frame:Same day, 24 hours, 48 hours
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Manual Therapy Techniques
Description:One of the following will be selected(1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Michigan State University
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Osteopathic Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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