A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers (The ARREST Study)

Study Overview
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Brief Summary
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The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

Detailed Description
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The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

Official Title
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A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers

Conditions
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Back Pain, Low Back Pain

Intervention / Treatment
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* Device: Aspen Horizon 627 LSO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o Moderate to complete disability (baseline ODI score of 21 to 80 percent) Exclusion Criteria: Pregnant patients Patients considering pregnancy Patients in any other investigational device or drug study Patients unwilling to return for follow up Patients unwilling to provide access to medical claims associated with pain management.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Aspen Horizon 627 LSO)<br>Patients receive a lumbar brace, Aspen Horizon 627 LSO, in addition to normal medical management | Device: Aspen Horizon 627 LSO<br> <br> |
| No Intervention: Medical Management<br>Normal medical management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 40% change in Oswestry Disability Index | Oswestry Disability Index | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid utilization | Change in Opioid utilization | 4 weeks, 8 weeks, 12 weeks | 
| Number of participants with treatment-related adverse events as assessed by questionnaire | Were any complications associated wearing of the brace noted in patients questionnaires | 4 weeks, 8 weeks, 12 weeks | 
| General Health Survey | SF36v2 Health Survey | 12 weeks |