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A Study of Lofexidine for Rapid Opioid Tapering in Adults
Rochester, MN
The purpose of this study is to assess the effects of lofexidine on opioid tapering in adults undergoing opioid tapering prior to elective lumbar spine surgery.
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Dorsal spinal cord stimulation vs medical management for the treatment of low back pain
Rochester, MN
The purpose of this study is to evaluate the effectiveness of BurstDRTM spinal cord stimulation, compared with comprehensive medical management, in improving pain and back-related physical function in patients suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
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Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
Jacksonville, FL
The purpose of this study is to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain; to investigate the effectiveness of HIFU, using the Neurolyser XR, in a rigorous randomized double-blind sham-controlled fashion. This study will allow the evaluation of a portable, non-invasive and simple to use HIFU method guided by a routine fluoroscopy.
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Systems That May Produce Central Sensitization Syndrome of LBP
Rochester, MN
The purpose of this study is to investigate the effects of Central Sensitization and Glymphatic flow in connection with chronic low back pain. Data will be assessed to determine the effect of these characteristics on the symptoms of low back pain. Future work from this pilot study will include a clinical trial to assess how these aspects can be altered to improve the outcomes of chronic low back pain.
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Magnetic Resonance Elastography of Myofascial Pain Syndrome
Rochester, MN
The purpose of this study is to develop MRE-based imaging biomarkers to measur the mechanical properties of the myofascial interface and determine if there are changes in these parameters in MPS patients and if these parameters can be used to monitor treatment responses and predict patient outcomes.
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A Study Comparing Effectiveness and Safety of SPIRA-A Anterior Lumbar Interbody Fusion Device to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 in Instrumented Lumbar Fusions
Rochester, MN
The purpose of this study is to evaluate if SPIRA-A Anterior Lumbar Interbody Fusion Device is equivalent in effectiveness and safety to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 when used in instrumented lumbar fusions.
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Study Evaluating the Side Effects of Bone Marrow-Derived Stem Cells When Injected Into the Facet Joints for the Treatment of Painful Arthropathies
Jacksonville, FL
The purpose of this study is to determine the safety and feasibility of allogeneic, culture-expanded BM-MSCs in subjects with painful facet joint arthropathy.
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Treating Negative Affect in Low Back Pain Patients (TNA-LBP)
Rochester, MN
The purpose of this study is to compare the effectiveness of combination therapy with antidepressants (AD), fear avoidance rehabilitation (EFAR) AD+EFAR vs. each treatment alone to improve pain, self-reported function, depression, and anxiety in patients with chronic low back pain and high negative affect.
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Study of Lumbar Discectomy with Additional Implantation of an Annular Closure Device in Patients with Large Postsurgical Annular Defects
Jacksonville, FL
The purpose of this study is to confirm the efficacy of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction in a US population.
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A Study to Evaluate the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
Rochester, MN
The purpose of this study is to assess the safety of the Angel® Concentrated Platelet Rich Plasma System and Angel® CPRP Processing Set to process Platelet Rich Plasma for intra-articular injection into four lumbar facet joints (2 levels) causing chronic low back pain.