Low Back Pain
Conditions
Keywords
Low back pain, Back brace, Lumbar orthoses, Lumbosacral orthoses, Low back pain treatment
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).
Interventions
OTHERInextensible LSO (stiff back support)
Cotton/nylon canvas back support with velcro fasteners.
OTHERExtensible LSO, a back support that is flexible
Back support is constructed from lycra and neoprene with velcro fasteners.
OTHERStandard of Care
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Score in the Patient Specific Activity Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 32 |
| 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. | 37 |
| Total | 98 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Inextensible Lumbosacral Orthoses and Standard of Care | Extensible Lumbosacral Orthoses Plus Standard of Care |
|---|---|---|---|---|
| Age, Customized Age | 45.0 years STANDARD_DEVIATION 16.6 | 48.4 years STANDARD_DEVIATION 15.3 | 50.4 years STANDARD_DEVIATION 14 | 48.8 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 98 Participants | 37 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 72 Participants | 29 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 26 Participants | 8 Participants | 10 Participants |
| Region of Enrollment United States | 29 participants | 98 participants | 37 participants | 32 participants |
| Sex: Female, Male Female | 18 Participants | 60 Participants | 20 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 38 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 32 | 0 / 37 |
| serious Total, serious adverse events | 0 / 29 | 0 / 32 | 0 / 37 |
Outcome results
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.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) | 2.4 units on a scale |
| Extensible Lumbosacral Orthoses Plus Standard of Care | Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) | 8.1 units on a scale |
| Inextensible Lumbosacral Orthoses and Standard of Care | Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) | 14.0 units on a scale |
Comparison: ANCOVA Adjusted for baseline scorep-value: 0.0195% CI: [2.2, 16.6]ANCOVA
p-value: 0.1695% CI: [-2, 12.6]ANCOVA
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.
Time frame: Baseline and 2-weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Change Score in the Patient Specific Activity Scale | -0.4 units on a scale |
| Extensible Lumbosacral Orthoses Plus Standard of Care | Change Score in the Patient Specific Activity Scale | -1.2 units on a scale |
| Inextensible Lumbosacral Orthoses and Standard of Care | Change Score in the Patient Specific Activity Scale | -1.8 units on a scale |
Comparison: Adjusted for baseline.p-value: 0.0195% CI: [-2.3, -0.4]ANCOVA
Comparison: Adjusted for baseline.p-value: 0.0595% CI: [-2.1, 0]ANCOVA