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

This study is currently recruiting participants.
Verified October 2016 by Toshihiko Kono, Tomidahama Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990365
First Posted: November 21, 2013
Last Update Posted: October 19, 2016
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.
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital
  Purpose
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.

Condition
Osteoporotic Vertebral Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures

Resource links provided by NLM:


Further study details as provided by Toshihiko Kono, Tomidahama Hospital:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osteoporotic patients with acute vertbral fracture
Criteria

Inclusion Criteria:

  • Patients with acute osteoporosis fractures

Exclusion Criteria:

  • Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Tomidahama Hospital
  More Information

Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT01990365     History of Changes
Other Study ID Numbers: TH No 6-3
First Submitted: November 15, 2013
First Posted: November 21, 2013
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
Vertebral fracture, low back pain, gips, mobility

Additional relevant MeSH terms:
Back Injuries
Fractures, Bone
Back Pain
Low Back Pain
Spinal Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Injuries