The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures

• Conditions: Osteoporotic Vertebral Fracture

• Registration Number: NCT01990365
• Lead Sponsor: Tomidahama Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with acute osteoporosis fractures

Exclusion Criteria

• Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between dynamic mobility of acute vertebral fracture body and low back pain	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.

Trial Locations

Locations (1)

Tomidahama Hospital; 🇯🇵 Yokkaichi, Mie, Japan