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

NCT02049931 | Completed Results

• 1 other identifier: Brace001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Compression Fracture

Keywords

osteoporosis, compression fracture, brace

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) at 12 Weeks

  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 Outcomes (4)

• Visual Analog Pain Scale (VAS) for Back Pain

  2 weeks, 6 weeks, 12 weeks after injury

• Oswestry Disability Index (ODI)

  at 2 weeks, 6 weeks, and 12 weeks after compression fracture.

• General Health Status

  at the initial enrollment and 12 weeks after compression fracture

• the Progression of Body Compression Ratio Over All Follow-up Assessments

  2 weeks, 6 weeks, and 12 weeks after compression fracture

Study Arms (3)

No brace group

EXPERIMENTAL

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

Rigid brace group

ACTIVE COMPARATOR

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

Soft brace group

ACTIVE COMPARATOR

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

Interventions

No brace treatment DEVICE

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

No brace group

Rigid brace 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.

Rigid brace group

Soft brace 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.

Soft brace group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (1)

• Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.

  PMID: 25471910 DERIVED

MeSH Terms

Conditions

Fractures, Compression; Osteoporosis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Professor Jin S. Yeom
• Organization: Seoul National University

highcervical@gmail.com

82-31-787-7195

Study Officials

• Ho-Joong Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 7, 2018
• Results First Posted: May 25, 2015

Record last verified: 2018-08