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)
NCT03100097 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2018-01-12
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.
Conditions
- Back Pain
- Low Back Pain
Interventions
- DEVICE
-
Aspen Horizon 627 LSO
Sponsors & Collaborators
-
Aspen Medical Products
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-16
- Primary Completion
- 2017-06-30
- Completion
- 2017-12-31
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