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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain
- Sponsor
- Aspen Medical Products
- Enrollment
- 62
- Primary Endpoint
- 40% change in Oswestry Disability Index
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
40% change in Oswestry Disability Index
Time Frame: 4 weeks
Oswestry Disability Index
Secondary Outcomes
- Change in Opioid utilization(4 weeks, 8 weeks, 12 weeks)
- General Health Survey(12 weeks)
- Number of participants with treatment-related adverse events as assessed by questionnaire(4 weeks, 8 weeks, 12 weeks)