- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060358
Assessment of Spinal Stability
February 5, 2013 updated by: University of Colorado, Denver
Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability
The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine.
The results will be used to accurately quantify NNZs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
25
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
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver
-
-
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
21 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.
Description
Inclusion Criteria:
- 21-45 years of age - typical working age in physically demanding jobs
- no history of low back injury or musculoskeletal disorder in the past one year
- any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race
- body mass index score less than 30
Exclusion Criteria:
- Younger than 21 or older than 45 years old (range not relevant to majority of physical labor force)
- previous injury, disorder, or illness related to the low back
- professional athletes
- professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.)
- pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy
Healthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
neuromuscular neutral zones
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bradley Davidson, Ph.D., University of Colorado, Denver
- Principal Investigator: Moshe Solomonow, Ph.D., M.D. (hon), University of Colorado, Denver
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
August 1, 2009
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
January 29, 2010
First Submitted That Met QC Criteria
January 29, 2010
First Posted (Estimate)
February 2, 2010
Study Record Updates
Last Update Posted (Estimate)
February 7, 2013
Last Update Submitted That Met QC Criteria
February 5, 2013
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0063
- 2586067 (Other Identifier: UC Denver Project Number)
- K99AT004983 (U.S. NIH Grant/Contract)
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.