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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No brace treatment | Device | Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Scale (VAS) for Back Pain | 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 weeks, 6 weeks, 12 weeks after injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho-Joong Kim, MD | Seoul National University Bundang Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25471910 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Brace Group | Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable. No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Brace Group | Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable. No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable. |
| BG001 | Rigid Brace Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks after injury |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Brace Group | Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable. No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jin S. Yeom | Seoul National University | 82-31-787-7195 | highcervical@gmail.com |
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| ID | Term |
|---|---|
| D050815 | Fractures, Compression |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
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| 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. |
|
| Oswestry Disability Index (ODI) | 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). | at 2 weeks, 6 weeks, and 12 weeks after compression fracture. |
| General Health Status | 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. | at the initial enrollment and 12 weeks after compression fracture |
| the Progression of Body Compression Ratio Over All Follow-up Assessments | 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 | 2 weeks, 6 weeks, and 12 weeks after compression fracture |
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. 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. Then, weaning period requires additional 4 weeks. |
| BG002 | 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. 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. Then, weaning period requires additional 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
|
|
| Secondary | Visual Analog Pain Scale (VAS) for Back Pain | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, 6 weeks, 12 weeks after injury |
|
|
|
| Secondary | Oswestry Disability Index (ODI) | 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). | Posted | Mean | Standard Deviation | units on a scale | at 2 weeks, 6 weeks, and 12 weeks after compression fracture. |
|
|
|
| Secondary | General Health Status | 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. | Posted | Mean | Standard Deviation | units on a scale | at the initial enrollment and 12 weeks after compression fracture |
|
|
|
| Secondary | the Progression of Body Compression Ratio Over All Follow-up Assessments | 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 | Posted | Mean | Standard Deviation | ratio | 2 weeks, 6 weeks, and 12 weeks after compression fracture |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. 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. | 0 | 20 | 0 | 20 |
| EG002 | 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. 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. | 1 | 20 | 0 | 20 |
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| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|
| 12 weeks after injury |
|
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| 12 weeks after injury |
|
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| SF-36 MCS at the initial enrollment |
|
| SF-36 MCS at 12 weeks after injury |
|
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| 12 weeks after injury |
|