Back to resultsComparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain (LSO LBP)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inextensible LSO (stiff back support)
Extensible LSO, a back support that is flexible
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Back brace, Lumbar orthoses, Lumbosacral orthoses, Low back pain treatment
Eligibility Criteria
Inclusion Criteria:
- chief complaint of lower back pain, with or without lower extremity (LE) symptoms
- 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics
Exclusion Criteria:
- Exclusion criteria are:
- previous spinal surgery
- workman's compensation or litigation is involved
- neurological disease or injury
- systemic inflammatory disease
- pulmonary disease which restricts breathing capacity
- current pregnancy
- acute fracture
- tumor or metastatic disease
- infection
- neurological disease
- the presence of pathological reflexes (e.g., Babinski)
- the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Standard of Care
Extensible lumbosacral orthoses plus standard of care
Inextensible lumbosacral orthoses and standard of care
Arm Description
Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01933399
First Posted
June 24, 2013
Last Updated
April 13, 2015
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01933399
Brief Title
Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain
Acronym
LSO LBP
Official Title
Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Back brace, Lumbar orthoses, Lumbosacral orthoses, Low back pain treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Arm Title
Extensible lumbosacral orthoses plus standard of care
Arm Type
Experimental
Arm Description
This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Arm Title
Inextensible lumbosacral orthoses and standard of care
Arm Type
Experimental
Arm Description
This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Intervention Type
Other
Intervention Name(s)
Inextensible LSO (stiff back support)
Intervention Description
Cotton/nylon canvas back support with velcro fasteners.
Intervention Type
Other
Intervention Name(s)
Extensible LSO, a back support that is flexible
Intervention Description
Back support is constructed from lycra and neoprene with velcro fasteners.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
Primary Outcome Measure Information:
Title
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)
Description
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.
Time Frame
Baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Change Score in the Patient Specific Activity Scale
Description
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.
Time Frame
Baseline and 2-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chief complaint of lower back pain, with or without lower extremity (LE) symptoms
150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics
Exclusion Criteria:
Exclusion criteria are:
previous spinal surgery
workman's compensation or litigation is involved
neurological disease or injury
systemic inflammatory disease
pulmonary disease which restricts breathing capacity
current pregnancy
acute fracture
tumor or metastatic disease
infection
neurological disease
the presence of pathological reflexes (e.g., Babinski)
the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Morrisette, PT, PhD
Organizational Affiliation
Medical Unversity of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain
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