Comparison of Extensible and Inextensible Lumbosacral Ort... | NCT01933399

Comparison of Extensible and Inextensible Lumbosacral Ort... | NCT01933399 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	Other	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.	Other: Standard of Care
Extensible lumbosacral orthoses plus standard of care	Experimental	This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter	Other: Extensible LSO, a back support that is flexible
Inextensible lumbosacral orthoses and standard of care	Experimental	This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.	Other: Inextensible LSO (stiff back support)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inextensible LSO (stiff back support)	Other	Cotton/nylon canvas back support with velcro fasteners.	Inextensible lumbosacral orthoses and standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)	Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.	Baseline and 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change Score in the Patient Specific Activity Scale	Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.

Contacts/Locations Module

Name	Affiliation	Role
David Morrisette, PT, PhD	Medical Unversity of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

Arm/Group Information

ID	Title	Description
FG000	Standard of Care	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
FG001	Extensible Lumbosacral Orthoses Plus Standard of Care	This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners.
FG002	Inextensible Lumbosacral Orthoses and Standard of Care	This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions. Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00029 subjects FG00132 subjects FG00237 subjects
COMPLETED		FG00029 subjects FG00132 subjects FG00237 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Standard of Care	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)

Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline and 2 weeks

ID	Title	Description
OG000	Standard of Care

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard of Care	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
David Morrisette, PhD	MUSC	843-792-2940		morrisdc@musc.edu

Condition Browse Module

ID	Term
D017116	Low Back Pain

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Intervention Browse Module

ID	Term
D059039	Standard of Care

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030
Asian	BG0000 BG0010 BG0020 BG0030
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030
Black or African American	BG00021 BG00122 BG00229 BG00372
White	BG0008 BG00110 BG0028 BG00326
More than one race	BG0000 BG0010 BG0020 BG0030
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	ANCOVA Adjusted for baseline score	ANCOVA		.01		Mean Difference (Final Values)	9.4			2-Sided	95	2.2	16.6			Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline. a priori threshold determined to be .05. no adjustments for multiple comparisons.	No	Superiority or Other
OG000 OG001		ANCOVA	Adjustment for baseline.	.16	a priori threshold determined to be .05. no adjustments for multiple comparisons.	Mean Difference (Final Values)	5.3			2-Sided	95	-2.0	12.6				No	Superiority or Other

Secondary

Change Score in the Patient Specific Activity Scale

Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.

Posted

Mean

95% Confidence Interval

units on a scale

Baseline and 2-weeks

ID	Title	Description
OG000	Standard of Care	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
OG001	Extensible Lumbosacral Orthoses Plus Standard of Care	This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners.
OG002	Inextensible Lumbosacral Orthoses and Standard of Care	This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions. Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners.

Units	Counts
Participants	OG00029 OG00132 OG00237

Title

Denominators