Assessment of Spinal Stability

Low Back Pain Clinical Trial

Official title:

Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060358
• Other study ID #: 08-0063
• Secondary ID: 2586067K99AT0049
• Status: Completed
• Phase: N/A
• First received: January 29, 2010
• Last updated: February 5, 2013
• Start date: August 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2010
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Low Back Pain
• Spine Stability

Intervention

Procedure:
• method (non-surgical) to measure neuromuscular neutral zones

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuromuscular neutral zones		one year	No