Assessment of Spinal Stability | NCT01060358

Studies
Assessment of Spinal Stability

NCT01060358

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Feb 7, 2013Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Spine Stability
Low Back Pain

Interventions

method (non-surgical) to measure neuromuscular neutral zones

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2586067	Other Identifier	UC Denver Project Number
K99AT004983	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

May 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Jan 29, 2010

First Posted Date

Feb 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
method (non-surgical) to measure neuromuscular neutral zones	Procedure		healthy

Measure	Description	Time Frame
neuromuscular neutral zones		one year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradley Davidson, Ph.D.	University of Colorado, Denver	Principal Investigator
Moshe Solomonow, Ph.D., M.D. (hon)	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided