- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745705
Cervical Spine Manipulation Affects on Balance and Proprioception
June 17, 2013 updated by: Emilio, University of Nevada, Las Vegas
Immediate Effects of Cervical Spine Manipulation on Balance and Joint Proprioception in Healthy Individuals
Cervical spine manipulation (CSM) is utilized by many health care practitioners in the management of patients with neck pain and headache.
How CSM works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects.
This study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following CSM.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a Neurocom Balancemaster.
Following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nevada
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Las Vegas, Nevada, United States, 89154
- Department of Physical Therapy, University of Nevada Las Vegas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy individuals between the ages of 18 and 60
Exclusion Criteria:
- current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cervical Spine Manipulation
Subjects will lie supine on a treatment table and receive a high velocity low amplitude thrust joint manipulation to their cervical spine in rotation to each side of the neck.
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|
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Sham Comparator: Manual Contact
Subjects will lie supine on a treatment table and have their suboccipital region gently cupped by the therapist for 30 seconds.
No movement or force will be applied, just simple manual contact.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical joint proprioception
Time Frame: 1 day (Immediately after the intervention)
|
Subjects wear a headband with a mounted laser pointer and sit 1 meter away from a wall.
They assume their comfortable neutral cervical posture and then close their eyes and extend their cervical spine and return to their neutral posture with eyes closed.
The laser pointer marks the point of return and we measure the difference between start and end points for error.
|
1 day (Immediately after the intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SMART Neurocom Balance Master
Time Frame: 1 day (Immediately after the intervention)
|
Subjects stand on a force plate on a SMART Neurocom Balance Master and complete a Sensory Organization Test (SOT) program which assesses somatosensory, visual and vestobular systems used in maintaining balance.
|
1 day (Immediately after the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
December 5, 2012
First Submitted That Met QC Criteria
December 7, 2012
First Posted (Estimate)
December 10, 2012
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1105-3780
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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