Load Quantitative MRI Study of Incipient LBP Patients.

Low Back Pain Clinical Trial

Official title:

Load Quantitative MRI Study of Incipient LBP Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01916811
• Other study ID #: 20130114
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2013
• Last updated: August 5, 2013
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2013
• Source: Central South University
• Contact: Lu Hongbin, M.D. & Ph.D.
• Phone: 86-0731-84327174
• Email: hongbinlu[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 27 Years

Eligibility

Inclusion Criteria:

1. Female between 18 and 27 years of age

2. Subject who has worked as a nurse less than three years and will continue working as a nurse no less than one year

3. Back pain has happened more than 2 times In the past 12 months(every time lasts 2 days or more),or never happened

4. Subjects who do not participate any other study concerning pain prevention currently and in the next year

5. According with magnetic resonance inspection standard

6. NO spectical low back pain and no other serious diseases in the other systems

Exclusion Criteria:

1. Subjects who has a family history of low back pain

2. Subjects who are Suffering from specific low back pain

3. Subjects who are suffering from serious somatic disease and/or psychic disease

4. Subjects who are suffering from chronic pain disease and need long-term use of drug therapy

5. Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery

6. Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically

7. Subjects who have had a spinal operation

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Low Back Pain

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the structure of lumbar	research the structure of facet joint,disc,muscle and ligment using quantitative MRI.	18 months	No
Secondary	the function of lumbar	research the function of facet joint,disc,muscle and ligment using quantitative MRI.	18 months	No