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

Not Applicable

Completed

• Conditions: Compression Fracture
• Interventions: Device: Rigid brace; Device: Soft brace; Device: No brace treatment

• Registration Number: NCT02049931
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2015-05-22
• Results First Posted: 2015-05-25
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-05
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rigid brace group	Rigid brace	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.
Soft brace group	Soft brace	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.
No brace group	No brace treatment	Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) at 12 Weeks	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).

Secondary Outcome Measures

Name	Time	Method
General Health Status	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.
Oswestry Disability Index (ODI)	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).
the Progression of Body Compression Ratio Over All Follow-up Assessments	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
Visual Analog Pain Scale (VAS) for Back Pain	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.