Trial Outcomes & Findings for Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace (NCT NCT02049931)
NCT ID: NCT02049931
Last Updated: 2018-08-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 weeks after injury
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
Baseline characteristics by cohort
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.25 years
STANDARD_DEVIATION 10.40 • n=5 Participants
|
66.75 years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
71.75 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
70.25 years
STANDARD_DEVIATION 10.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after injuryThe 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).
Outcome measures
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
|---|---|---|---|
|
Oswestry Disability Index (ODI) at 12 Weeks
|
35.95 units on a scale
Interval 25.42 to 46.47
|
33.54 units on a scale
Interval 23.79 to 43.29
|
37.83 units on a scale
Interval 26.77 to 48.9
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 12 weeks after injuryThe 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.
Outcome measures
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
|---|---|---|---|
|
Visual Analog Pain Scale (VAS) for Back Pain
2 weeks after injury
|
5.9 units on a scale
Standard Deviation 1.9
|
5.5 units on a scale
Standard Deviation 1.8
|
6.8 units on a scale
Standard Deviation 1.7
|
|
Visual Analog Pain Scale (VAS) for Back Pain
6 weeks after injury
|
4.6 units on a scale
Standard Deviation 2.0
|
5.2 units on a scale
Standard Deviation 1.8
|
6.3 units on a scale
Standard Deviation 2.0
|
|
Visual Analog Pain Scale (VAS) for Back Pain
12 weeks after injury
|
4.9 units on a scale
Standard Deviation 2.0
|
3.4 units on a scale
Standard Deviation 2.1
|
4.2 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
|---|---|---|---|
|
Oswestry Disability Index (ODI)
2 weeks after injury
|
56.84 units on a scale
Standard Deviation 17.06
|
53.32 units on a scale
Standard Deviation 13.56
|
64.19 units on a scale
Standard Deviation 16.12
|
|
Oswestry Disability Index (ODI)
6 weeks after injury
|
47.05 units on a scale
Standard Deviation 16.22
|
52.53 units on a scale
Standard Deviation 14.52
|
57.62 units on a scale
Standard Deviation 16.53
|
|
Oswestry Disability Index (ODI)
12 weeks after injury
|
42.12 units on a scale
Standard Deviation 16.12
|
38.73 units on a scale
Standard Deviation 13.78
|
44.25 units on a scale
Standard Deviation 17.12
|
SECONDARY outcome
Timeframe: at the initial enrollment and 12 weeks after compression fractureThe 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.
Outcome measures
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
|---|---|---|---|
|
General Health Status
SF-36 PCS at the initial enrollment
|
29.70 units on a scale
Standard Deviation 13.55
|
34.18 units on a scale
Standard Deviation 14.58
|
29.87 units on a scale
Standard Deviation 11.87
|
|
General Health Status
SF-36 PCS at 12 weeks after injury
|
31.15 units on a scale
Standard Deviation 12.45
|
32.75 units on a scale
Standard Deviation 14.23
|
33.53 units on a scale
Standard Deviation 11.52
|
|
General Health Status
SF-36 MCS at the initial enrollment
|
41.79 units on a scale
Standard Deviation 10.31
|
48.29 units on a scale
Standard Deviation 14.93
|
42.21 units on a scale
Standard Deviation 11.75
|
|
General Health Status
SF-36 MCS at 12 weeks after injury
|
36.53 units on a scale
Standard Deviation 11.64
|
37.85 units on a scale
Standard Deviation 14.62
|
34.63 units on a scale
Standard Deviation 12.43
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, and 12 weeks after compression fractureThe 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
Outcome measures
| Measure |
No Brace Group
n=20 Participants
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.
|
Rigid Brace Group
n=20 Participants
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.
|
Soft Brace Group
n=20 Participants
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.
|
|---|---|---|---|
|
the Progression of Body Compression Ratio Over All Follow-up Assessments
2 weeks after injury
|
0.62 ratio
Standard Deviation 0.05
|
0.67 ratio
Standard Deviation 0.03
|
0.70 ratio
Standard Deviation 0.05
|
|
the Progression of Body Compression Ratio Over All Follow-up Assessments
6 weeks after injury
|
0.58 ratio
Standard Deviation 0.04
|
0.66 ratio
Standard Deviation 0.04
|
0.65 ratio
Standard Deviation 0.03
|
|
the Progression of Body Compression Ratio Over All Follow-up Assessments
12 weeks after injury
|
0.57 ratio
Standard Deviation 0.05
|
0.63 ratio
Standard Deviation 0.03
|
0.64 ratio
Standard Deviation 0.03
|
Adverse Events
No Brace Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rigid Brace Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soft Brace Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Brace Group
n=20 participants at risk
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.
|
Rigid Brace Group
n=20 participants at risk
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.
|
Soft Brace Group
n=20 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place