Clinical Trials

Connect with our team to learn more about getting involved in a clinical trial

Part of the ISPPC's mission to deliver exceptional multi-specialty care is a commitment to expanding therapeutic options for our patients. Through clinical research, we directly support the advancement of pain medicine--and as a research participant, you can, too!

Our clinical research program is just one way our practice seeks to empower patients with choice and access. Clinical trials allow patients to access novel, investigational therapies at little to no cost.

Led by Dr. Desai, a nationally-recognized clinical investigator in pain and musculoskeletal medicine, ISPPC physicians are at the forefront of cutting-edge pain care and spine and musculoskeletal medicine. Ask your doctor if one of our trials could be right for you. 

For more information, please reach out to us at research@isppcenter.com

What are clinical trials?

Clinical trials are a necessary precursor to the public availability of novel therapies. That is, before the FDA approves a new drug or device for use--and before insurance companies agree to cover these treatments--rigorous clinical testing must be conducted to ensure that the drug or device is safe and effective. Because these therapies are investigational, clinics that carry out these kinds of studies must adhere to strict safety monitoring requirements set by medical ethics professionals. Many patients opt to participate in these trials for early access to novel therapies at little to no cost or simply to contribute to the advancement of science and medicine. 

What can I expect as a research participant?

Every research study is different, but most studies include three phases: screening, treatment, and follow-up.

During the screening office visit, you'll meet with a member of our research team and carefully review all the study details in depth on a document called the informed consent form. You'll then discuss your medical and surgical history, and, typically, complete some questionnaires about your pain and function. You might see one of the study doctors for a physical exam. Sometimes, this visit includes a blood draw or an X-ray.

Treatments vary by study: there may be only one dose of study medicine, or there might be the option for retreatment. Device trials might be temporary or permanent. No matter what the study involves, our team will work to ensure you are well-informed and comfortable every step of the way.

Some clinical trials are randomized. In these studies, there are multiple treatment options, and each participant is randomly assigned to one of them. Sometimes, these studies are also blinded, which means that study participants won't know which treatment they're receiving. (In a double-blinded study, study doctors and research assistants also won't know what treatment each patient gets.) This is an important part of study design, particularly in pain medicine. Blinding helps decrease bias when patients report subjective measures, like pain, emotion, and daily function. If there is ever an emergency situation, the study doctor can readily identify which treatment a patient received so that they can be treated appropriately.

Lastly, the follow-up phase is intended to assess if and for how long the study treatment is effective. It also allows our study doctors to monitor for any side effects, short- or long-term, and make sure they're cared for properly. During these visits, the researcher will ask how you're doing, review what medications you take, and ask you to fill out some questionnaires. You may need to meet with a study doctor for a physical exam or get a blood draw at some of these appointments. These visits are usually brief and can sometimes be completed over the phone. Follow-ups are typically every two to four weeks for the first few months after study treatment, then become less frequent. Study follow-up can last anywhere from a few weeks to several years.

How much does it cost to participate?

In almost all clinical trials, the study treatment is provided at no cost to you. In addition, any blood tests, X-rays, or office visits that are done only for research will not be billed to your insurance. Any other medical care outside the study will be billed to you or your insurance as usual.

Many trials provide modest compensation to participants to help ease the burden of travel to the study site and to demonstrate appreciation for their time.

What kinds of trials do you offer?

Our physicians are experienced in studies involving peripheral nerve stimulators and spinal cord stimulators, stem cell therapy, epidural and intraarticular steroid injections, and more. Our currently enrolling clinical trials are listed below. 

KNEE OA TRIAL   

Are you dissatisfied with your current knee osteoarthritis pain treatment? 

This phase III clinical trial studies the effectiveness of SL1002, a one-time injection that targets six nerves around the knee, compared to a saline placebo. SL1002 is a type of chemoneurolytic agent, meaning this chemical is injected near carefully-selected target nerves to temporarily damage the nerves and reduce pain signals in the area.

What to Expect:

• Phase 1 (Screening): Up to 30 days of initial evaluation, which includes a 7-day daily pain diary and a standard diagnostic lidocaine nerve block to confirm your knee's pain pathways are receptive.
• Phase 2 (Treatment Visit): A single Day 1 outpatient injection procedure under local anesthesia.
• Phase 3 (Follow-up): Post-treatment check-ins at Week 2, Month 1, Month 2, Month 3, Month 4, and Month 6.

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

• Age 40 or older with ongoing knee pain for at least 6 months.
• Currently dissatisfied with your current medication or physical therapy.
• No total or partial knee replacements in the index knee.

Eligible participants may earn up to $1,300 for time and travel.

THE CRPS-RISE TRIAL   

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Find out whether an investigational drug may reduce pain and other CRPS symptoms with warm subtype of CRPS-1.

A prospective, Phase III clinical trial exploring the first potential FDA-approved pharmacological treatment in the U.S. for Complex Regional Pain Syndrome Type 1 (CRPS-1). This trial evaluates AMBTX-01 (sodium neridronate): an aminobisphosphonate designed to target inflammatory and bone-absorption mechanisms that drive pain and swelling in early-stage, "warm" CRPS-1. 

What to Expect: 

• Phase 1 (Screening): Up to 6 weeks of initial screening to confirm a warm-subtype diagnosis (incorporating clinical Budapest criteria and a confirming triple-phase bone scan).
• Phase 2 (Treatment): Four (4) intravenous infusions administered slowly (at least 2 hours each) on Days 1, 4, 7, and 10.
• Phase 3 (Follow-up): Efficacy and safety clinic visits on Weeks 3, 6, and 12, with follow-up phone calls at Day 13 and Week 9.

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

• Age 18 or older with CRPS-1 diagnosed in a single affected limb.
• Symptom onset is very recent (6 months or less prior to study randomization).
• Signs of "warm" CRPS: Swelling/edema in the limb combined with redness and local warmth.

Eligible participants may earn up to $1019 with potential travel coverage.