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Trial record 1 of 1 for:    NCT02049931
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Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

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ClinicalTrials.gov Identifier: NCT02049931
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : May 25, 2015
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Compression Fracture
Interventions Device: No brace treatment
Device: Rigid brace
Device: Soft brace
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 20 20 20
Completed 17 15 17
Not Completed 3 5 3
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
72.25  (10.40) 66.75  (11.00) 71.75  (7.96) 70.25  (10.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
13
  65.0%
14
  70.0%
14
  70.0%
41
  68.3%
Male
7
  35.0%
6
  30.0%
6
  30.0%
19
  31.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 60
1.Primary Outcome
Title Oswestry Disability Index (ODI) at 12 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 20 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
35.95
(25.42 to 46.47)
33.54
(23.79 to 43.29)
37.83
(26.77 to 48.90)
2.Secondary Outcome
Title Visual Analog Pain Scale (VAS) for Back Pain
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
3.Secondary Outcome
Title Oswestry Disability Index (ODI)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
4.Secondary Outcome
Title General Health Status
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
5.Secondary Outcome
Title the Progression of Body Compression Ratio Over All Follow-up Assessments
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: ratio
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Brace Group Rigid Brace Group Soft Brace Group
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
No Brace Group Rigid Brace Group Soft Brace Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
No Brace Group Rigid Brace Group Soft Brace Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      1/20 (5.00%)    
Cardiac disorders       
Death *  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Brace Group Rigid Brace Group Soft Brace Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Jin S. Yeom
Organization: Seoul National University
Phone: 82-31-787-7195
EMail: highcervical@gmail.com
Layout table for additonal information
Responsible Party: Jin S. Yeom, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02049931    
Other Study ID Numbers: Brace001
First Submitted: January 28, 2014
First Posted: January 30, 2014
Results First Submitted: April 15, 2014
Results First Posted: May 25, 2015
Last Update Posted: August 7, 2018