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Neck PainNCT00022828

3-D Laser Imaging to Analyze Neck Movement

An observational study of Neck Pain and Manipulation, Spinal, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neck Pain, Manipulation, Spinal
What is being tested?
3-D Laser Imaging Device
Type of treatment
Medical device
How many people
134 participants
Where
2 sitesUnited States
Study dates
Jan 2003to Jan 2006
Phase
Observational
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Northern Illinois University

    DeKalb, Illinois, 60115

  • Laser and Image Processing Lab

    Huntsville, Alabama, 35762

Other trials in United States

About this study

Official title: 3-D Laser Imaging for Cervical Spine Motion Analysis

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.

Read the 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.

Being tested
3-D Laser Imaging Device
Keywords
Laser, Cervical, Spinal, Spine, Neck, Illinois
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-D Laser Imaging DeviceDevice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2001 (estimated)
  2. Study startJan 2003
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
134 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022828
Sponsor's protocol ID
R15AR047296
Other IDs
NIAMS-063
Status last verified
Oct 2006
First submitted
14 Aug 2001
Last updated
4 Jan 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Manipulation, Spinal, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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.

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 4 Jan 2007.

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