Clinical Trials


 

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ISPPC is not only devoted to delivering the best in pain care & spine and musculoskeletal medicine, but also to furthering the scope of what is medically possible. Our currently enrolling clinical trials are listed below. 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 trial today, and together we will push the boundaries of science and medicine.

For more information, please email research@isppcenter.com

What are clinical trials?

Clinical trials are research studies aimed at evaluating the success of new treatments. Prior to a drug or device being approved for general use, it must go through rigorous testing to ensure it is safe and effective in people. Part of this process is reviewing data and having safety monitoring boards track the progress of the trial. 

The physicians and research team at ISPPC maintain an avid interest in research and our portfolio includes many clinical trials focused on medication injections, radiofrequency, and spinal cord stimulation. Participants are carefully selected for our clinical trials, and the team at ISPPC will make sure you understand the scope of the study and what you can expect throughout the duration of the trial. 

 

COMFORT TRIAL

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT)

 

This prospective, minimal risk, multi-centered, randomized control study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation (PNS) plus conventional medical management (CMM) vs. CMM alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

You may be a candidate for this trial if you meet the following criteria:

  • 18-80 years old
  • Diagnosed post-surgical/post-traumatic peripheral neuralgia in the low back, shoulder or knee and foot (including ankle)
  • Chronic (at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region

 

RISE STUDY

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

This is a double-blind, randomized, controlled study 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 postsurgical neuropathic pain (PSNP). The patch will be applied by a healthcare professional to the skin in the painful area. This may reduce your symptoms and can be repeated if symptoms return.

You may be a candidate for this trial if you meet the following criteria:

  • ≥18 years old
  • Documented diagnosis of post-surgical neuropathic pain (PSNP)
  • Documented diagnosis of probable or definite PSNP

 

ACTiVION-I KNEE OSTEOARTHRITIS CLINICAL TRIAL

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

Is osteoarthritis of the knee causing you pain? Our site is currently enrolling patients for a trial exploring an investigational therapy for knee osteoarthritis. The investigational study therapy (TG-C) has a mixture of chondrocyte cells and irradiated, transduced GP2-293 cells that are injected into the knee. The intended goal of this investigational therapy is to reduce pain and delay the progression of the disease through slowing cartilage degeneration.

You may be eligible to participate if you meet the following criteria:

  • Age 40+
  • Mild to moderate knee osteoarthritis (OA)
  • Minimal to moderate knee OA pain
  • Willing to refrain from opioid usage

 

SPRINT PNS FOR SHOULDER PAIN 

A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain

 

The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that delivers stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.

You may be eligible to participate if you meet the following criteria:

  • Diagnosed with degenerative changes within the shoulder complex
  • Shoulder pain score at baseline >5
  • Scheduled for or interested in scheduling a commercial SPRINT PNS procedure

 

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