Spine StabilityNCT01060358
Assessment of Spinal Stability
An observational study of Spine Stability and Low Back Pain, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Stability, Low Back Pain
- What is being tested?
- method (non-surgical) to measure neuromuscular neutral zones
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Spine Stability, Low Back Pain
- Being tested
- method (non-surgical) to measure neuromuscular neutral zones
- Keywords
- lumbar spine, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method (non-surgical) to measure neuromuscular neutral zonesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| healthy | Healthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury. Receives: Procedure: method (non-surgical) to measure neuromuscular neutral zones |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuromuscular neutral zones
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine StabilityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Bradley Davidson, Ph.D., Principal investigator, University of Colorado, DenverMoshe Solomonow, Ph.D., M.D. (hon), Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060358
- Sponsor's protocol ID
- 08-0063
- Other IDs
- 2586067, K99AT004983
- Status last verified
- Jan 2010
- First submitted
- 29 Jan 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability
- ClinicalTrials.gov ID
- NCT01060358
- Acronym / sponsor ID
- 08-0063
- Conditions
- Spine Stability, Low Back Pain
- Keywords
- lumbar spine, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy | – | Procedure: method (non-surgical) to measure neuromuscular neutral zonesHealthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| method (non-surgical) to measure neuromuscular neutral zones | Procedure or surgery | healthy |
Primary outcome
neuromuscular neutral zones
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Davidson, Ph.D. principal investigator
University of Colorado, Denver
Moshe Solomonow, Ph.D., M.D. (hon) principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Stability and Low Back Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuromuscular neutral zones (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013; AzTrials last refreshed its copy on 26 Oct 2026.