Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

• 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: Seoul National University Hospital
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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

Baseline Characteristics

Arm/Group Title		No Brace Group	Rigid Brace Group	Soft Brace Group	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Oswestry Disability Index (ODI) at 12 Weeks
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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)
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Brace Group	Rigid Brace Group	Soft Brace Group
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	No Brace Group		Rigid Brace Group		Soft Brace Group
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	--/--		--/--		--/--
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
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Professor Jin S. Yeom
• Organization: Seoul National University
• Phone: 82-31-787-7195
• EMail: highcervical@gmail.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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