Research

Developing New Solutions

As a national center for research, we’ve been involved in studies for abdominal pain, for headache, for failed back surgery as well as the innovative area of regenerative medicine. Recently we just completed a study for back pain with introduction of stem cells into the intervertebral disc with amazing success.

As we continue to be a national center for research, newer treatments for the treatment of pain become available on a monthly basis. Below are some of the studies we’ve been involved in for the last several years.

Current Clinical Trials

A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disk Disease.

Purpose: The purpose of this study is to determine if SB-01 is an effective treatment for patients Moderate to Severe Lumbar Degenerative Disk Disease of the Lumbar Spine, a "MODEL" study.

Enrollment Status: Currently enrolling.

PROLONG Prospective, Multi-center, Open-label, Post-market Study (PROLONG) using Burst Dorsal Root Spinal Cord Stimulator in the Treatment of Chronic Pain.

Purpose: Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system.

Enrollment Status: Not enrolling, active patients.

Safety and Efficacy of Intravenous Xo-Flo in the Treatment of Complex Regional Pain Syndrome (CRPS).

Purpose: The purpose of this study is to determine if Mesenchymal Stem Cell (MSC) derived Extracellular Vesicle (EVs) isolates are an effective therapy for patients with Complex Regional Pain Syndrome (CRPS).

Enrollment Status: Not enrolling,

Completed, Pending Publishing.

Previous Trials

Nuvectra Hi-Fi. A Multicenter, Prospective, Randomized, Double-Blind, Post-Market Clinical Trial Comparing Ultra-High versus Traditional Pulse Widths using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Chronic Back and/or Leg Pain

MESOBLAST A Prospective, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of rexlemestrocel-L Alone or Combined with Hyaluronic Acid (HA) in Subjects with Chronic Low Back Pain

NEVRO SENZA , Clinical Trial to Assess the Feasibility of a Spinal Cord System in the Treatment of Chronic Abdominal Pain Study.

SENZA, Multiple Waveform Spinal Cord Stimulator Trial –Multi Center Observational study using a single SCS that can deliver multiple stimulation frequencies and waveforms allowing a more definitive identification of the neurostimulative approaches optimally suited to each individual. Test subjects were used that had previous trial failure with stimulation held constant at 10 kHz only.