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

Osteoporotic Vertebral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990365
• Other study ID #: TH No 6-3
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: October 18, 2016
• Start date: January 2012
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Tomidahama Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with acute osteoporosis fractures

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Fractures, Bone
• Low Back Pain
• Osteoporotic Vertebral Fracture
• Spinal Fractures

Locations

Country	Name	City	State
Japan	Tomidahama Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Tomidahama Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between dynamic mobility of acute vertebral fracture body and low back pain	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	Yes