The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01990365|
Recruitment Status : Recruiting
First Posted : November 21, 2013
Last Update Posted : October 19, 2016
|Condition or disease|
|Osteoporotic Vertebral Fracture|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
- Relationship between dynamic mobility of acute vertebral fracture body and low back pain [ Time Frame: Up to 36 months ]
The investigators plan to analyze 300 patients who presented with acute back pain and were diagnosed as having acute OVFs on MRI.
All radiographs were taken at the initial visit. Fracture mobility was determined by comparing cross-table supine lateral radiographs with sitting lateral radiographs (dynamic radiography). Mobility was considered present when a measurable change in vertebral body height occurred between supine and sitting radiographs.We also evaluate low back pain using visual analog scale (VAS) score.
Then the patients undergo external fixation using Gips. After Gips fixation, dynamic radiography was performed again to evaluate reduction of dynamic mobility of the OVF body. VAS score was also evaluated after external fixation.
We investigate patients' background such as age, sex, bone mineral density, etc.
We performed statical analyses to determine the factors which related to low back pain after acute OVFs, especially fracture mobility.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990365
|Yokkaichi, Mie, Japan, 510-8008|
|Contact: Rui Niimi, MD, PhD (81)-59-365-0023 firstname.lastname@example.org|