Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

3-D Laser Imaging to Analyze Neck Movement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Northern Illinois University
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00022828
First received: August 14, 2001
Last updated: January 2, 2007
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Neck Pain
Manipulation, Spinal
Device: 3-D Laser Imaging Device
Phase 1

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: 3-D Laser Imaging for Cervical Spine Motion Analysis

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 134
Study Start Date: January 2003
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study participants must be 18 years old or older.
  • Study participants 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. The rest of the participants will have no complaints of neck pain.

Exclusion Criteria:

  • Children under 18 years of age.
  • Individuals unable to attain the test positions with active neck motions.
  • Individuals unable to understand and follow simple verbal commands spoken in English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022828

Locations
United States, Alabama
Laser and Image Processing Lab
Huntsville, Alabama, United States, 35762
United States, Illinois
Northern Illinois University
DeKalb, Illinois, United States, 60115
Sponsors and Collaborators
Northern Illinois University
Investigators
Principal Investigator: Mohamed A. Seif, PhD Alabama A&M University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00022828     History of Changes
Other Study ID Numbers: R15 AR47296, NIAMS-063
Study First Received: August 14, 2001
Last Updated: January 2, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Laser
Cervical
Spinal
Spine
Neck
Illinois

ClinicalTrials.gov processed this record on November 25, 2014