Our Mission Statement
The Center for Clinical Studies is the official research division of the Ainsworth Institute and is committed to bringing the future of medicine to the forefront of today. By participating in research studies and clinical trials, our physicians are able to offer the most cutting edge treatments to our patients that are not yet available to the public at-large.
Who We Are
Our center conducts clinical trials and participates in the research and development of therapies and technologies that will allow the field of pain management to grow to be able to allow patients even better outcomes.
Our research department gives patients access to the most advanced technologies in existence and works to develop strategies in conjunction with industry experts to allow individuals the best care with the least risk.
What Sets Us Apart
The Center for Clinical Studies has thrust the Ainsworth Institute to the forefront of medicine and is what sets us apart from every other pain management center out there. No other private practice or academic institute in the area is as involved in research, clinical trials or publication as the Ainsworth Institute.
Current Clinical Trials & Research Studies
EVOKE STUDY – Closed Loop Stimulation for Chronic Low Back and/or Leg Pain
Our institute has been chosen to participate in the extremely prestigious EVOKE study – a phase 3 clinical trial on a device that can communicate with the spinal cord and adapt and pain patterns change. We are 1 of just 11 sites selected to take part in this historic clinical trial.
Spinal cord stimulation has been used to treat various types of chronic pain for decades. While many have benefited from this therapy over time, there remains a great deal of room for improvement with regards to percentage of people who respond and the degree of relief one can achieve. In this clinical trial, we will be studying a remarkable new stimulator technology that may very well change the face of medicine forever.
ENROLLMENT – Open
MESOBLAST STUDY – Stem Cell Therapy for Chronic Discogenic Low Back Pain
The Ainsworth Institute of Pain Management has been selected to join a phase 3 clinical trial studying the safety and efficacy of mesenchymal stems for the treatment of chronic low back back pain.
Low back pain affects 9 out of 10 Americans and is the 5th most common reason to go to the doctor. This trial will study the use of stem cells to potentially repair damaged spinal discs and decrease low back pain. It is being conducted in several cities around the country; we are the only cite in the trip-state area!
ENROLLMENT – Open
TARGET Study – Dorsal Root Ganglion Stimulation for the Treatment of Complex Regional Pain Syndrome (CRPS)
St. Jude Medical is conducting a phase IV, post market study, clinical trial on the DRG stimulator. The FDA recently approved this amazing therapy on February 2016 for the treatment of Complex Regional Pain Syndrome (CRPS).
The phase III clinical trial, known as the ACCURATE study, showed that DRG stimulation was effective in 93.3% of patients with CRPS. The TARGET study is being conducted at a handful of sites around the United States – the Ainsworth Institute is the only site in New York State, or the tri-state area.
ENROLLMENT – Open
CREATE-1 STUDY – CRPS Treatment Evaluation 2 Study
The Ainsworth Institute has been selected to join a worldwide clinical trial studying the efficacy and safety of the medication AXS-02 for the treatment of Complex Regional Pain Syndrome Type 1 (CRPS-1).
CRPS (aka RSD) is painful and debilitating condition affecting both men and women. What causes CRPS is a mystery and without treatment, it can progress to the point where a simple gust of wind can bring a person to their knees from pain. This study is phase 3 clinical trial evaluating an oral medication as a potential treatment for CRPS.
ENROLLMENT – Open
GRATIFY-1 Study – Radiofrequency Ablation (RFA) of the Knee before Surgery to Improve Post-Op Recovery
In some cases, knee surgery is unavoidable – despite our best efforts. Our center is investigating the use of conventional RFA on the knee before surgery to see if patients have improved pain and recovery after surgery.
By using RFA on the genicular nerves outside the knee, our doctors can reduce pain inside the knee during the post-operative period – similar to the regional anesthesia given in the operating room just before the operation. The difference is this regional anesthesia will wear off in matter of hours, whereas RFA can last for months! With decreased pain after surgery, our doctors theorize patients will need less pain medication and make bigger strides in rehab and physical therapy leading to better function in a shorter period of time.
ENROLLMENT – Pending
PHANTOM LIMB PAIN – High Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
The Ainsworth Institute of Pain Management has been selected to join an ongoing clinical trial that will investigate the use of Neuromodulation for the treatment of Phantom Limb Pain. This new technology will study the effect of a new type of electrode placed on the sciatic nerve combined with a new type of waveform not currently used to treat this painful syndrome in amputees. Our Center for Clinical Studies has partnered with the Department of Neurosurgery at Lenox Hill Hospital here in Manhattan to perform this amazing study. The study itself will be conducted out of our flagship office in Manhattan.
ENROLLMENT – Open
KNEE PAIN STUDY – Coolief™ Cooled Radiofrequency Ablation to Treat Chronic Knee Pain
The Ainsworth Institute is investigating the use of Cooled Radiofrequency Ablation to treat chronic knee pain. Our center is one of just 12 sites throughout the country (the only center in the tri-state area) who has been asked to participate in this groundbreaking study.
Chronic knee osteoarthritis (OA) is one of the most common diseases of advanced age with as many as 1 million sufferers in the United States alone. Typically, the only definitive treatments are injections – and if injections are unsuccessful, a knee replacement. Close to 700,000 people received knee replacements each year according to the CDC. This study will investigate the use of Cooled Radiofrequency as a safe alternative to surgery.
ENROLLMENT – CLOSED
Our physicians have been publishing in textbooks and peer-reviewed journals as well as lecturing around the country to share the results of our findings. These publications have been cited by additional researchers in their own studies as well as used by other pain management doctors to treat their own patients – thus aiding in the advancement of medicine and betterment of the field.
Center for Clinical Studies
The Ainsworth Institute prides itself on having strong relationships with Industry & Medical Device Companies such as St Jude Medical, Halyard, Elliquence & Flowonix. These relationships allow our doctors to stay on the cutting edge and help drive innovation in the field of pain management. Most importantly, it gives our Institute access to treatments not yet available to the general public within the United States.