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
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: 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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014