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)
Launched by ASPEN MEDICAL PRODUCTS · Mar 29, 2017
Trial Information
Current as of May 29, 2025
Terminated
Keywords
ClinConnect 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.
Gender
ALL
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.
About Aspen Medical Products
Aspen Medical Products is a leading provider of innovative medical devices and orthopedic solutions, dedicated to enhancing patient care and outcomes. With a focus on the development and commercialization of advanced products for spinal and orthopedic applications, Aspen Medical Products leverages cutting-edge technology and rigorous clinical research to address the diverse needs of healthcare professionals and their patients. Committed to quality and excellence, the company strives to improve mobility and support recovery, making a positive impact in the field of rehabilitation and medical treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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