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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Compression Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No brace group

Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.

Group Type EXPERIMENTAL

No brace treatment

Intervention Type DEVICE

Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.

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.

Group Type ACTIVE_COMPARATOR

Rigid brace

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Soft brace

Intervention Type DEVICE

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.

Interventions

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No brace treatment

Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No