Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

August 5, 2018 updated by: Jin S. Yeom, Seoul National University Hospital

The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace

The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
  • compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.

Exclusion Criteria:

  • the presence of more than two recent vertebral fractures,
  • pathologic malignant compression fractures,
  • neurologic complications,
  • a history of previous injury or surgery to the fractured level,
  • inability to complete the questionnaires about pain and disability.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No brace group
Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
Device: No brace treatment
Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
Active Comparator: Rigid brace group
Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Device: Rigid brace
In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
Active Comparator: Soft brace group
Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
Device: Soft brace
In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI) at 12 Weeks
Time Frame: 12 weeks after injury
The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
12 weeks after injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Pain Scale (VAS) for Back Pain
Time Frame: 2 weeks, 6 weeks, 12 weeks after injury
The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
2 weeks, 6 weeks, 12 weeks after injury
Oswestry Disability Index (ODI)
Time Frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
General Health Status
Time Frame: at the initial enrollment and 12 weeks after compression fracture
The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
at the initial enrollment and 12 weeks after compression fracture
the Progression of Body Compression Ratio Over All Follow-up Assessments
Time Frame: 2 weeks, 6 weeks, and 12 weeks after compression fracture
The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level
2 weeks, 6 weeks, and 12 weeks after compression fracture

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ho-Joong Kim, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brace001

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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