An interventional study of No brace treatment and Rigid brace in Compression Fracture, sponsored by Seoul National University Hospital. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 60 is below the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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
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
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
Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
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.
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) 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
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
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.
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
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
| Milestone | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 17 | 15 | 17 |
| Not completed | 3 | 5 | 3 |
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).
| units on a scale | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| Oswestry Disability Index (ODI) at 12 Weeks | 35.95 (25.42 to 46.47) | 33.54 (23.79 to 43.29) | 37.83 (26.77 to 48.90) |
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.
| units on a scale | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| 2 weeks after injury | 5.9 ± 1.9 | 5.5 ± 1.8 | 6.8 ± 1.7 |
| 6 weeks after injury | 4.6 ± 2.0 | 5.2 ± 1.8 | 6.3 ± 2.0 |
| 12 weeks after injury | 4.9 ± 2.0 | 3.4 ± 2.1 | 4.2 ± 1.9 |
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).
| units on a scale | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| 2 weeks after injury | 56.84 ± 17.06 | 53.32 ± 13.56 | 64.19 ± 16.12 |
| 6 weeks after injury | 47.05 ± 16.22 | 52.53 ± 14.52 | 57.62 ± 16.53 |
| 12 weeks after injury | 42.12 ± 16.12 | 38.73 ± 13.78 | 44.25 ± 17.12 |
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.
| units on a scale | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| SF-36 PCS at the initial enrollment | 29.70 ± 13.55 | 34.18 ± 14.58 | 29.87 ± 11.87 |
| SF-36 PCS at 12 weeks after injury | 31.15 ± 12.45 | 32.75 ± 14.23 | 33.53 ± 11.52 |
| SF-36 MCS at the initial enrollment | 41.79 ± 10.31 | 48.29 ± 14.93 | 42.21 ± 11.75 |
| SF-36 MCS at 12 weeks after injury | 36.53 ± 11.64 | 37.85 ± 14.62 | 34.63 ± 12.43 |
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
| ratio | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| 2 weeks after injury | 0.62 ± 0.05 | 0.67 ± 0.03 | 0.70 ± 0.05 |
| 6 weeks after injury | 0.58 ± 0.04 | 0.66 ± 0.04 | 0.65 ± 0.03 |
| 12 weeks after injury | 0.57 ± 0.05 | 0.63 ± 0.03 | 0.64 ± 0.03 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Brace Group | — | 0/20 (0%) | 0/20 (0%) |
| Rigid Brace Group | — | 0/20 (0%) | 0/20 (0%) |
| Soft Brace Group | — | 1/20 (5%) | 0/20 (0%) |
| Event | No Brace Group | Rigid Brace Group | Soft Brace Group |
|---|---|---|---|
| DeathCardiac disorders | 0/20 | 0/20 | 1/20 |
| Age, Continuous(years) | No Brace Group | Rigid Brace Group | Soft Brace Group | Total |
|---|---|---|---|---|
| Mean | 72.25 ± 10.40 | 66.75 ± 11.00 | 71.75 ± 7.96 | 70.25 ± 10.26 |
| Sex: Female, Male(Participants) | No Brace Group | Rigid Brace Group | Soft Brace Group | Total |
|---|---|---|---|---|
| Female | 13 | 14 | 14 | 41 |
| Male | 7 | 6 | 6 | 19 |
| Region of Enrollment(participants) | No Brace Group | Rigid Brace Group | Soft Brace Group | Total |
|---|---|---|---|---|
| Korea, Republic of | 20 | 20 | 20 | 60 |
No study locations are listed for this record.
The record gives a start of Dec 2012, a primary completion of Oct 2013 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.
Results were first posted in May 2015, 1 year 7 months after primary completion.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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