Compression Fracture
Conditions
Keywords
osteoporosis, compression fracture, brace
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.
Interventions
DEVICENo brace treatment
Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
DEVICERigid 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.
DEVICESoft 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. Then, weaning period requires additional 4 weeks. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | No Brace Group | Rigid Brace Group | Soft Brace Group | Total |
|---|---|---|---|---|
| Age, Continuous | 72.25 years STANDARD_DEVIATION 10.4 | 66.75 years STANDARD_DEVIATION 11 | 71.75 years STANDARD_DEVIATION 7.96 | 70.25 years STANDARD_DEVIATION 10.26 |
| Region of Enrollment Korea, Republic of | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 14 Participants | 41 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 1 / 20 |
Outcome results
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).
Time frame: 12 weeks after injury
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Brace Group | Oswestry Disability Index (ODI) at 12 Weeks | 35.95 units on a scale |
| Rigid Brace Group | Oswestry Disability Index (ODI) at 12 Weeks | 33.54 units on a scale |
| Soft Brace Group | Oswestry Disability Index (ODI) at 12 Weeks | 37.83 units on a scale |
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.
Time frame: at the initial enrollment and 12 weeks after compression fracture
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Brace Group | General Health Status | SF-36 MCS at the initial enrollment | 41.79 units on a scale | Standard Deviation 10.31 |
| No Brace Group | General Health Status | SF-36 MCS at 12 weeks after injury | 36.53 units on a scale | Standard Deviation 11.64 |
| No Brace Group | General Health Status | SF-36 PCS at the initial enrollment | 29.70 units on a scale | Standard Deviation 13.55 |
| No Brace Group | General Health Status | SF-36 PCS at 12 weeks after injury | 31.15 units on a scale | Standard Deviation 12.45 |
| Rigid Brace Group | General Health Status | SF-36 MCS at the initial enrollment | 48.29 units on a scale | Standard Deviation 14.93 |
| Rigid Brace Group | General Health Status | SF-36 PCS at 12 weeks after injury | 32.75 units on a scale | Standard Deviation 14.23 |
| Rigid Brace Group | General Health Status | SF-36 PCS at the initial enrollment | 34.18 units on a scale | Standard Deviation 14.58 |
| Rigid Brace Group | General Health Status | SF-36 MCS at 12 weeks after injury | 37.85 units on a scale | Standard Deviation 14.62 |
| Soft Brace Group | General Health Status | SF-36 MCS at 12 weeks after injury | 34.63 units on a scale | Standard Deviation 12.43 |
| Soft Brace Group | General Health Status | SF-36 PCS at the initial enrollment | 29.87 units on a scale | Standard Deviation 11.87 |
| Soft Brace Group | General Health Status | SF-36 PCS at 12 weeks after injury | 33.53 units on a scale | Standard Deviation 11.52 |
| Soft Brace Group | General Health Status | SF-36 MCS at the initial enrollment | 42.21 units on a scale | Standard Deviation 11.75 |
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).
Time frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Brace Group | Oswestry Disability Index (ODI) | 2 weeks after injury | 56.84 units on a scale | Standard Deviation 17.06 |
| No Brace Group | Oswestry Disability Index (ODI) | 12 weeks after injury | 42.12 units on a scale | Standard Deviation 16.12 |
| No Brace Group | Oswestry Disability Index (ODI) | 6 weeks after injury | 47.05 units on a scale | Standard Deviation 16.22 |
| Rigid Brace Group | Oswestry Disability Index (ODI) | 6 weeks after injury | 52.53 units on a scale | Standard Deviation 14.52 |
| Rigid Brace Group | Oswestry Disability Index (ODI) | 2 weeks after injury | 53.32 units on a scale | Standard Deviation 13.56 |
| Rigid Brace Group | Oswestry Disability Index (ODI) | 12 weeks after injury | 38.73 units on a scale | Standard Deviation 13.78 |
| Soft Brace Group | Oswestry Disability Index (ODI) | 12 weeks after injury | 44.25 units on a scale | Standard Deviation 17.12 |
| Soft Brace Group | Oswestry Disability Index (ODI) | 2 weeks after injury | 64.19 units on a scale | Standard Deviation 16.12 |
| Soft Brace Group | Oswestry Disability Index (ODI) | 6 weeks after injury | 57.62 units on a scale | Standard Deviation 16.53 |
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
Time frame: 2 weeks, 6 weeks, and 12 weeks after compression fracture
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 12 weeks after injury | 0.57 ratio | Standard Deviation 0.05 |
| No Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 6 weeks after injury | 0.58 ratio | Standard Deviation 0.04 |
| No Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 2 weeks after injury | 0.62 ratio | Standard Deviation 0.05 |
| Rigid Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 12 weeks after injury | 0.63 ratio | Standard Deviation 0.03 |
| Rigid Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 2 weeks after injury | 0.67 ratio | Standard Deviation 0.03 |
| Rigid Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 6 weeks after injury | 0.66 ratio | Standard Deviation 0.04 |
| Soft Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 6 weeks after injury | 0.65 ratio | Standard Deviation 0.03 |
| Soft Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 2 weeks after injury | 0.70 ratio | Standard Deviation 0.05 |
| Soft Brace Group | the Progression of Body Compression Ratio Over All Follow-up Assessments | 12 weeks after injury | 0.64 ratio | Standard Deviation 0.03 |
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.
Time frame: 2 weeks, 6 weeks, 12 weeks after injury
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 2 weeks after injury | 5.9 units on a scale | Standard Deviation 1.9 |
| No Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 12 weeks after injury | 4.9 units on a scale | Standard Deviation 2 |
| No Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 6 weeks after injury | 4.6 units on a scale | Standard Deviation 2 |
| Rigid Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 2 weeks after injury | 5.5 units on a scale | Standard Deviation 1.8 |
| Rigid Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 6 weeks after injury | 5.2 units on a scale | Standard Deviation 1.8 |
| Rigid Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 12 weeks after injury | 3.4 units on a scale | Standard Deviation 2.1 |
| Soft Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 2 weeks after injury | 6.8 units on a scale | Standard Deviation 1.7 |
| Soft Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 12 weeks after injury | 4.2 units on a scale | Standard Deviation 1.9 |
| Soft Brace Group | Visual Analog Pain Scale (VAS) for Back Pain | 6 weeks after injury | 6.3 units on a scale | Standard Deviation 2 |