Objective Kinematic Correlates of Palpatory Diagnosis

Cervical Spine Clinical Trial

Official title:

Objective Kinematic Correlates of Palpatory Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728247
• Other study ID #: Bush-headneck
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: September 17, 2010
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women and minors

Study Design

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

Related Conditions & MeSH terms

• Cervical Spine

Intervention

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

Locations

Country	Name	City	State
United States	Biomechanical Design Research Laboratory	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-dimensional kinematics		Same day, 24 hours, 48 hours	No