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

Seoul National University

Status: Completed

Conditions: Compression Fracture

Treatments: Device: Rigid brace; Device: No brace treatment; Device: Soft brace

Study type: Interventional

Funder types: Other

Identifiers

NCT02049931

Brace001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

No brace group

Experimental group

Description:

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

Treatment:

Device: No brace treatment

Rigid brace group

Active Comparator group

Description:

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.

Treatment:

Device: Rigid brace

Soft brace group

Active Comparator group

Description:

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.

Treatment:

Device: Soft brace