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Completed

NCT Number: NCT02049931

Comparison of Treatments of Osteoporotic Compression Fracture 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.

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Key information

Conditions

Compression Fracture Bone Diseases Bone Diseases, Metabolic Fractures, Bone Fractures, Compression Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No brace treatment

Device

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

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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).

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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