Trial record 3 of 15 for:    Open Studies | "Spinal Fractures"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Tomidahama Hospital
Sponsor:
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital
ClinicalTrials.gov Identifier:
NCT01990365
First received: November 15, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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 Tomidahama Hospital:

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: 300
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT01990365     History of Changes
Other Study ID Numbers: TH No 6-3
Study First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014