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

October 18, 2016 updated by: Toshihiko Kono, Tomidahama Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Mie
      • Yokkaichi, Mie, Japan, 510-8008
        • Recruiting
        • Tomidahama Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Osteoporotic patients with acute vertbral fracture

Description

Inclusion Criteria:

  • Patients with acute osteoporosis fractures

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomidahama Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH No 6-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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