Clinical Trials


 

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ISPPC is not only devoted to delivering the best in pain-management care, but also to furthering the scope of what is medically possible. Listed below are the clinical trials that ISPPC is currently recruiting for. These studies are designed to help provide you with pain relief at little to no cost with the possibility of modest compensation for time and travel. Consider enrolling in a clinical study today, and together we will push the boundaries of science and medicine.

 

What are clinical trials?

Clinical trials are research programs to determine the effectiveness of new tests and treatments. Before a new procedure is approved for general use, it goes through rigorous testing to ensure its safety and efficacy for use on people.

Before the physicians at International Spine Pain & Performance open a clinical trial, the treatment goes through extensive development and testing. The trial also needs to be confirmed by data and approved by safety monitoring boards, which monitor the progress of the test. The team maintains an avid interest in research and serves as the principal investigator on many clinical trials, including studies on radiofrequency ablation and spinal cord stimulation.

Participants are carefully selected, and the team at ISPP Center makes sure you understand the scope of the trial and what you can expect.

 

 

OPEN ENROLLMENT


A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness StimRouter Neuromodulation System in Subjects with Chronic Pain of Peripheral Nerve Origin

This study involves the StimRouter™ for the treatment of chronic pain in the arms, legs, and trunk. The StimRouter™ has already been approved by the FDA for chronic pain and is currently in commercial use. The doctor uses a needle to place a thin lead (wire) under the skin. The target nerve is then stimulated with electrical current delivered by the system to provide pain relief. This study will allow us to monitor the StimRouter™ for a period of up to 5 years. It will allow us to evaluate your experience at pre-implant, implant, and post-implant during this period of time. 

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A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

This study involves a Peripheral Nerve Stimulation (PNS) system which delivers mild electrical stimulation to the muscles in your low back to provide pain relief. The System includes up to four leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators) for 60 days. This is a 1:1 randomized study, meaning approximately half of the people in the study will receive electrical stimulation and about half will receive the standard of care treatment. Those randomized into the control group will have the option to get the PNS system after 1 year. This study will last approximately 26 months.

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Spinal Cord Stimulation in the treatment of Chronic, Intractable Pain using the Nalu™ Neurostimulation System (nPower™-US)

The purpose of this research study is to confirm the safety, comfort and effectiveness of the Nalu Neurostimulation System to treat chronic pain of the legs and back. The Nalu Neurostimulation System is a spinal cord stimulator which is placed in your back and spine surgically. The Nalu device is capable of producing various waveforms to stimulate the spinal cord to treat pain. This study is completed in two phases: temporary trial followed by the permanent trial if patients respond successfully to the temporary trial. The total length of time you will be in the study is approximately 5 months but may last as long as 9 months.

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A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI6603 in Subjects with Lumbar Disc Herniation (Phase 3)

The purpose of this study is to evaluate the efficacy and long-term safety of SI-6603 in subjects with a lumbar disc herniation by monitoring them for 1 year after they are either given a single study drug (SI-6603) injection into the tissue between the bones in the spine (where the disc herniation has occurred) or a control procedure (a needle will be inserted through your skin and into the lumbar muscle near the affected disc, but will not enter the disc, and nothing will be injected). This is a 1:1 randomized study, therefore, you should participate in this study only if you are willing to receive either the study drug or no drug (the control procedure). Participation is expected to last approximately 1 year.

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Discogenic Low Back Pain Registry

The purpose of this study is to complement and integrate data collected in ongoing randomized-controlled clinical studies to aid in establishing payor coverage in the United States (US) for VIA Disc with real-world data. This is a prospective registry. If you choose to participate, you will be asked to complete short surveys that will be sent to you electronically at enrollment, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months. You will be able to complete these surveys without having to return to your physician’s clinic.

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A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis

The purpose of this study is to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed with knee osteoarthritis. This is a 1:1 randomized study, therefore, you should participate in this study only if you are willing to receive either the study drug or no drug (the control procedure). Participation is expected to last approximately 48 weeks.

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Treatment of Chronic, Intractable Pain using the Nalu Neurostimulation System: A Prospective Registry

The purpose of this study is to gather real-world data to assess the performance and functionality of the Nalu neurostimulation system to improve future systems. This is a prospective registry. If you choose to participate, you will be asked to answer questions about your Nalu neurostimulation system remotely every 3- to 6 months. Participation is expected to last approximately 24 months. 


ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation (RESTORE)

The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management. This is a 1:1 randomized study, meaning approximately half of the people in the study will receive electrical stimulation and about half will receive the standard of care treatment. Those randomized into the control group will have the option to get the ReActiv8 Stimulation Therapy after 1 year. This study will last approximately 2 years

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An Interventional, Phase III, Double-blind, Randomized, Controlled, Parallel-group, Multi-site, Clinical Trial Evaluating the Efficacy and Safety of Qutenza in Subjects With Post-surgical Neuropathic Pain

The purpose of this study is to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe post-surgical neuropathic pain (PSNP). This is a 1:1 randomized study, meaning approximately half of the people in the study will receive Qutenza (capsaicin 8% topical system) and about half will receive low-dose capsaicin control (capsaicin 0.04% topical system). Participation is expected to last approximately 44 weeks.

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