Ensayos clínicos

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.

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

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

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

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 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 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 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 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 primary purpose of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen.

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 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 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 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 compare postsurgical pain control following local infiltration analgesia and bupivacaine HCl with EXPAREL, versus without EXPAREL, in adult subjects undergoing open lumbar spinal fusion surgery. The study will also compare additional effectiveness, safety, and health economic outcomes.

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.

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 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 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 observe changes in bowel pattern based on gum-chewing, examine bowel function after anterior lumbar interbody fusion, measure length of time to return of bowel function after anterior lumbar interbody fusion, compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care, measure the hospital length of stay amongst study groups, and measure post-operative pain amongst study groups.