The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
Verified November 2015 by Tomidahama Hospital
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital
First received: November 15, 2013
Last updated: November 3, 2015
Last verified: November 2015
Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.
Osteoporotic Vertebral Fracture
||Observational Model: Case-Only
Time Perspective: Prospective
||The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
Primary Outcome Measures:
- Relationship between dynamic mobility of acute vertebral fracture body and low back pain [ Time Frame: Up to 36 months ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2017 (Final data collection date for primary outcome measure)
Many patients of acute OVFs present with low back pain. While there are also many patients without low back pain even if acute OVFs occurred. The mechanism of low back pain after acute OVFs is well unknown. We set up a hypothesis that low back pain results from vertebral body mobility, which refers to a change of vertebral height or configuration with changes in body positioning. The main objective of this study is to reveal the relationship between vertebral body mobility and low back pain.
|Ages Eligible for Study:
||45 Years to 100 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Osteoporotic patients with acute vertbral fracture
- Patients with acute osteoporosis fractures
- Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01990365
||Toshihiko Kono, Head of Hospital, Tomidahama Hospital
History of Changes
|Other Study ID Numbers:
TH No 6-3
|Study First Received:
||November 15, 2013
||November 3, 2015
||Japan: Institutional Review Board
Keywords provided by Tomidahama Hospital:
Vertebral fracture, low back pain, gips, mobility
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2016
Low Back Pain
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries