Cervical SpineNCT00728247
Objective Kinematic Correlates of Palpatory Diagnosis
A study testing Manual Therapy Techniques in people with Cervical Spine, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine
- What is being tested?
- Manual Therapy Techniques
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females over the age of 18 and up to 100 years of age
Who cannot join
- Pregnant women and minors
Trial locations and contacts
1 site in 1 country.
United States1 site
Biomechanical Design Research Laboratory
East Lansing, Michigan, 48824
About this study
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.
Read the 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.
- Conditions
- Cervical Spine
- Being tested
- Manual Therapy Techniques
- Keywords
- Cervical Spine, Kinematics, Manipulation, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy TechniquesProcedure or surgery
One of the following will be selected(1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional kinematics
Measured: Same day, 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728247
- Sponsor's protocol ID
- Bush-headneck
- Status last verified
- Sep 2010
- First submitted
- 31 Jul 2008
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Kinematic Correlates of Palpatory Diagnosis
- ClinicalTrials.gov ID
- NCT00728247
- Acronym / sponsor ID
- Bush-headneck
- Conditions
- Cervical Spine
- Keywords
- Cervical Spine, Kinematics, Manipulation, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and Females over the age of 18 and up to 100 years of age
Key exclusion criteria (1 listed)
- Pregnant women and minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy TechniquesOne of the following will be selected(1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method | Procedure or surgery | – |
Primary outcome
Three-dimensional kinematics
Time frame: Same day, 24 hours, 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy Techniques in people with Cervical Spine, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional kinematics (time frame: Same day, 24 hours, 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2010.