Assessment of Spinal Stability

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01060358
First received: January 29, 2010
Last updated: February 5, 2013
Last verified: January 2010
  Purpose

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.


Condition Intervention
Spine Stability
Low Back Pain
Procedure: method (non-surgical) to measure neuromuscular neutral zones

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • neuromuscular neutral zones [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy
Healthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury.
Procedure: method (non-surgical) to measure neuromuscular neutral zones

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060358

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Bradley Davidson, Ph.D. University of Colorado, Denver
Principal Investigator: Moshe Solomonow, Ph.D., M.D. (hon) University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01060358     History of Changes
Other Study ID Numbers: 08-0063, 2586067, K99AT004983
Study First Received: January 29, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
lumbar spine
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014