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| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2001 | ||||
| Last Updated Date | January 2, 2007 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00022828 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | 3-D Laser Imaging to Analyze Neck Movement | ||||
| Official Title ICMJE | 3-D Laser Imaging for Cervical Spine Motion Analysis | ||||
| Brief Summary | The goal of this research project is to develop a new system that uses lasers to provide 3-dimensional (3-D) images of the cervical spine (the seven spinal bones in the neck) in a moving person. Doctors and researchers could use this system to examine people with spinal disorders and to learn more about how the spine works. The laser technique would be better than existing imaging methods because it would provide 3-D views of the cervical spine and would not expose patients to radiation. These two features would make a laser system a safer and more effective tool than other imaging systems. This technique should be suitable for a wide variety of uses because the sensitivity of the measurement can be adjusted depending on what is being studied. The benefits of this research will include helping doctors and other health practitioners to detect and diagnose painful spinal disorders more effectively. This should lead to improved treatment and management of spinal disorders. |
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| Detailed Description | An improved method of spinal visualization is important because the examination and treatment of people with diagnoses such as scoliosis, spinal instability, and painful cervical spine and lumbar disorders depend on good spinal imaging. A system that would allow three-dimensional analysis of the spine in a moving person without the risk and limitations of radiation would greatly enhance the research and interventions needed to improve our understanding of spine position and movement. Moreover, it is extremely important for physicians, physical therapists, athletic trainers, coaches, and movement scientists to rely on accurate yet reliable devices for measuring the spine during activity and research. The objective of this study is to develop a novel automated, nondestructive 3-D laser imaging system for cervical spine motion analysis. The imaging system is based on shadow Moirý interferometry and finger pattern analysis. The proposed technique would be superior to existing methods such as radiography because of its potential to allow 3-D visualization and its elimination of patient exposure to radiation. These two attributes would make a laser system a safer and more effective tool. We hypothesize that the laser-based system will surpass conventional motion analysis systems such as video motion analysis systems, inclinometers, flexible rulers, goniometers, and posture grids in accuracy, reliability, and validity of measurements of spinal motion and position. The technique possesses several advantages with respect to simplicity, versatility and suitability for operation in different environments. The sensitivity of the measurement can be adjusted based on the nature of the object under investigation. This makes the technique suitable for a wide variety of applications. The benefits of these basic studies will include assisting physician and other allied health practitioners to more effectively detect and diagnose painful spinal disorders. This ultimately should enhance the treatment and management of spinal disorders. We plan to test the device on 134 people whom we will recruit from Northern Illinois University and the surrounding community. Thirty-four study participants (25%) will be patients seeking medical, chiropractic, or physical therapy intervention for complaints of neck pain from the Northern Illinois University Health Service and Northern Illinois area medical, chiropractic, and physical therapy facilities. The rest of the participants will have no complaints of neck pain. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Longitudinal, Convenience Sample, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: 3-D Laser Imaging Device | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 134 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00022828 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R15 AR47296, NIAMS-063 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | Northern Illinois University | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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