Clinical Trials

The purpose of the present study is to quantify the degree of modulation, if any, in the perioperative inflammatory response associated with statins use. Specifically, we hypothesize that:

In a population of patients undergoing elective orthopedic spine surgery, administration of a specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a decrease in perioperative inflammatory markers when compared to patients not taking statins

What is the incidence and etiology of bone overgrowth in protein versus other bone graft?

The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. We hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.

Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited ...

The purpose of this study is to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.

The purpose of this pilot phase study is to assess functionality and ease of use of an exercise monitoring system and decide whether any modifications are necessary before beginning a larger study using this system.

This research study is designed to evaluate the efficacy of Tuina therapy (Chinese massage therapy) compared to physiotherapy for low back pain.

This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain. 

This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in subjects with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc

The purpose of this study is to determine the usefulness of combining PET scan activity and MRI image biomarkers for the clinical management of spinal joint low back pain.

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

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. 

The purpose of this study is to evaluate if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation

The purpose of this study is to document the safety, clinical effectiveness and cost-effectiveness of high-frequency HF10™ Therapy, delivered through the Senza system, in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.

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.

The objective of this study is to compare the effectiveness of (A) a standardized general risk information sheet only, (B) a standardized general risk information sheet plus a probabilistic risk tool, (C) standardized sheet plus narrative enhanced probabilistic risk tool on a variety of patient reported and patient centered outcomes related to pain treatment and the risks and benefits of opioid prescriptions for common, acute pain conditions.

The aim of this project is to explore the utility of exoskeletons as a way of mitigating work-related back and neck musculoskeletal pain resulting from increased physical workload and fatigue in vascular and endovascular surgeons. Specifically, this project will assess the ability of passive exoskeletons to reduce the muscular demand and pain associated with quasi-static awkward postures assumed by surgeons while performing operations. Also, the influence of using exoskeletons on surgical task dexterity will be evaluated.

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.

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.

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.

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.

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.

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.

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.

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. 

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.

The purpose of this study is to develop, in close collaboration with stakeholders and the Mayo Clinic Spine Center, an evidence-based decision aid for the management of acute and sub-acute cervical and lumbar radiculopathies – “Options in Back Pain Management.”

The purpose of this study is to evaluate the safety and effectiveness of the investigational treatment compared to the control, and obtain indication expansion for Infuse™ use in one and two level TLIFprocedures.