Trial Outcomes & Findings for Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain (NCT NCT01933399)

NCT ID: NCT01933399

Last Updated: 2015-04-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: Baseline and 2 weeks
• Results posted on: 2015-04-30

Participant Flow

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	29	32	37
Overall Study COMPLETED	29	32	37
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

Baseline characteristics by cohort

Measure	Standard of Care n=29 Participants 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.	Extensible Lumbosacral Orthoses Plus Standard of Care n=32 Participants 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.	Inextensible Lumbosacral Orthoses and Standard of Care n=37 Participants 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.	Total n=98 Participants Total of all reporting groups
Age, Customized Age	45.0 years STANDARD_DEVIATION 16.6 • n=5 Participants	48.8 years STANDARD_DEVIATION 15.6 • n=7 Participants	50.4 years STANDARD_DEVIATION 14 • n=5 Participants	48.4 years STANDARD_DEVIATION 15.3 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	38 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants	98 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	22 Participants n=7 Participants	29 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	29 participants n=5 Participants	32 participants n=7 Participants	37 participants n=5 Participants	98 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks

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.

Outcome measures

Measure	Standard of Care n=29 Participants 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.	Extensible Lumbosacral Orthoses Plus Standard of Care n=32 Participants 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.	Inextensible Lumbosacral Orthoses and Standard of Care n=37 Participants 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.
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)	2.4 units on a scale Interval -2.2 to 7.1	8.1 units on a scale Interval 2.8 to 13.4	14.0 units on a scale Interval 8.2 to 19.8

SECONDARY outcome

Timeframe: Baseline and 2-weeks

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.

Outcome measures

Measure	Standard of Care n=29 Participants 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.	Extensible Lumbosacral Orthoses Plus Standard of Care n=32 Participants 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.	Inextensible Lumbosacral Orthoses and Standard of Care n=37 Participants 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.
Change Score in the Patient Specific Activity Scale	-0.4 units on a scale Interval -1.3 to 0.4	-1.2 units on a scale Interval -1.9 to -0.5	-1.8 units on a scale Interval -2.6 to -1.0

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extensible Lumbosacral Orthoses Plus Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inextensible Lumbosacral Orthoses and Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Morrisette, PhD

MUSC

Phone: 843-792-2940

Email: morrisdc@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place