Low Back PainNCT01916811
Load Quantitative MRI Study of Incipient LBP Patients.
An observational study of Low Back Pain, run by Central South University at 1 site in China.
Trial summary
The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 27 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jul 2014
- 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 18 to 27 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: young female nurse
Who may be able to join
- Female between 18 and 27 years of age
- Subject who has worked as a nurse less than three years and will continue working as a nurse no less than one year
- Back pain has happened more than 2 times In the past 12 months(every time lasts 2 days or more),or never happened
- Subjects who do not participate any other study concerning pain prevention currently and in the next year
- According with magnetic resonance inspection standard
- NO spectical low back pain and no other serious diseases in the other systems
Who cannot join
- Subjects who has a family history of low back pain
- Subjects who are Suffering from specific low back pain
- Subjects who are suffering from serious somatic disease and/or psychic disease
- Subjects who are suffering from chronic pain disease and need long-term use of drug therapy
- Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
- Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
- Subjects who have had a spinal operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Lu Hongbin, M.D. & Ph.D., 86-0731-84327174, hongbinlu@hotmail.com
About this study
The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low back pain.
Read the detailed description
Low back pain is a common clinical disease seriously affects the quality of people's lives. And this disease takes up a large proportion in the crowd. Incipient lumbago is hard to diagnose and often hidden morbidity. If early symptoms are ignored by patients, it will greatly influence the quality of life in the future. This study will use 3.0T MRI to distinguish the difference of lumbar small joints, intervertebral discs, ligaments and muscle between the normal and the pain.
Firstly, we recruit nurses with low back pain in one group, with the normal as control. Then the subject will accept 3.0T MRI scanning at the same time. Before scanning we will determine the MRI sequence to make sure the imageis are clear enough. At last, we will analysis the photos in the image processing workstation, reconstruct the anatomical structure in the scanning area. All of this is to find a possible reason or explanation in the occurrence of incipient lumbago through the comparison of two group's images.
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Load quantitative MRI
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
the structure of lumbar
research the structure of facet joint,disc,muscle and ligment using quantitative MRI.
Measured: 18 months
Secondary outcomes (1)
the function of lumbar
research the function of facet joint,disc,muscle and ligment using quantitative MRI.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbin Lu, Central South University
- Investigators
- Lu Hongbin, M.D. & Ph.D., Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916811
- Sponsor's protocol ID
- 20130114
- Status last verified
- Aug 2013
- First submitted
- 3 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Load Quantitative MRI Study of Incipient LBP Patients.
- ClinicalTrials.gov ID
- NCT01916811
- Acronym / sponsor ID
- 20130114
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Load quantitative MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 6 Aug 2013 (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 mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low back pain.
Detailed description
Low back pain is a common clinical disease seriously affects the quality of people's lives. And this disease takes up a large proportion in the crowd. Incipient lumbago is hard to diagnose and often hidden morbidity. If early symptoms are ignored by patients, it will greatly influence the quality of life in the future. This study will use 3.0T MRI to distinguish the difference of lumbar small joints, intervertebral discs, ligaments and muscle between the normal and the pain.
Firstly, we recruit nurses with low back pain in one group, with the normal as control. Then the subject will accept 3.0T MRI scanning at the same time. Before scanning we will determine the MRI sequence to make sure the imageis are clear enough. At last, we will analysis the photos in the image processing workstation, reconstruct the anatomical structure in the scanning area. All of this is to find a possible reason or explanation in the occurrence of incipient lumbago through the comparison of two group's images.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 27 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young female nurse
Key inclusion criteria (6 listed)
- Female between 18 and 27 years of age
- Subject who has worked as a nurse less than three years and will continue working as a nurse no less than one year
- Back pain has happened more than 2 times In the past 12 months(every time lasts 2 days or more),or never happened
- Subjects who do not participate any other study concerning pain prevention currently and in the next year
- According with magnetic resonance inspection standard
Key exclusion criteria (7 listed)
- Subjects who has a family history of low back pain
- Subjects who are Suffering from specific low back pain
- Subjects who are suffering from serious somatic disease and/or psychic disease
- Subjects who are suffering from chronic pain disease and need long-term use of drug therapy
- Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the structure of lumbar
Time frame: 18 months
research the structure of facet joint,disc,muscle and ligment using quantitative MRI.
1 secondary outcome
the function of lumbar
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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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.
Lu Hongbin, M.D. & Ph.D. principal investigator
Xiangya Hospital of Central South University
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 Low Back Pain, run by Central South University at 1 site in China.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Aug 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Hongbin, M.D. & Ph.D. (86-0731-84327174, hongbinlu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the structure of lumbar (time frame: 18 months). 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 6 Aug 2013.