Our Research

The Advanced Interventional Pain Clinic is leading the way to establish national standards regarding pain management. Research supports the interdisciplinary approach as the best way to treat pain. The Advanced Interventional Pain Clinic is dedicated to the advancement of new and improved medications to aide in the treatment of the chronic pain patient. Check back periodically for any new clinical trials.

You must meet criteria to be considered for enrollment. There is no cost to you for your participation. Some trials offer compensation for time and travel. You can also enroll if you are a patient at any NPI location and can travel to Winter Park.

To see if you would qualify for one of our trials, please ask to see the research nurse or call 407-203-7936 or 407-622-7246. You can also ask your NPI physician for more information.

DOWNLOAD OUR CLINICAL TRIAL BROCHURE

Our Current Studies

Center Overview

Our research department, is currently conducting clinical trials in our Winter Park and Port St. Lucie offices. We are a full time, dedicated site, with full time certified coordinators, Principal and sub-investigators.

Our unique interdisciplinary treatment approach has been determined to be the most effective methodology according to the American Academy of Pain Management. We have the ability to conduct clinical trials involving all areas of the chronic pain syndrome.

Mission Statement

”The Advanced Interventional Pain Clinic is a clinical research investigative site dedicated to providing our patients with qualified professionals who utilize good clinical practices to ensure the patient’s safety and wellbeing. Through clinical trials, our patients are offered access to new medical treatments and devices. We pride ourselves on providing quality data to our study sponsors, which is crucial in maintaining the safety and efficacy of the trials in which we participate. It is our duty to the people we serve in our community to provide the highest ethical standard of care and the opportunity to improve their quality of life through clinical trials.”

Patient Demographics

Our patient population is primarily between the ages of 40 to 75. We treat patients from the age of 18 and up. Chronic pain patients have many different diagnosis and issues they are being treated for. It is a very comprehensive specialty. Our chronic pain patient database consists of over 6000 patients. We can draw patients from 3 different surrounding counties from both of our central locations. Our patient population allows us to draw from a geriatric population as well as younger groups of patients. Chronic pain diseases include all age groups. We not only draw from age related disease patients but from traumatic injury patients as well.

Meet our Team of Investigators

Principal Investigator in Orlando, FLCherian K. Sajan, M.D., PI/Sub Investigator

Dr. Sajan has been with National Pain Institute since 2011. He completed a pain fellowship with us and went on to become an attending physician, principal investigator and sub-investigator. Dr Sajan is now the medical director of National Pain Institute Florida. Dr. Sajan is Board Certified in Physical Medicine and Rehabilitation and Pain Management.

He is NIH trained for Human Research Subject protection and is GCP trained before every new trial. Dr. Sajan is committed to the research department and is actively involved in study feasibility, recruitment and assessment of our research patients.


Principal Investigator in Orlando, FLAnthony F. Afong, M.D., Principal Investigator, M.D., Principal Investigator

Dr. Afong has been with National Pain Institute since 2006. He started with us as a fellow as well and went on to become medical director and principal investigator of our Port St Lucie, Fl, office.
Dr. Afong is NIH and GCP trained and has conducted trials in Chronic Low Back Pain, Opioid Induced Constipation and Intrathecal Hydromorphone for Chronic Pain.

He is instrumental in the study feasibility and recruitment aspects of pretrial selection for his site.


Principal Investigator in Orlando, FLCesar A. Lassalle-Nieves, M.D., Principal Investigator

Dr. Lassalle has been with the National Pain Research Institute since 2012. After completing a pain fellowship in our pain management practice and serving as a subinvestigator on our clinical trials, he became Medical Director for the Advanced Interventional Pain Clinic and a Principal Investigator for the National Pain Research Institute, Orlando office.

Dr. Lassalle is GCP certified through Clinical Trials Network NIDA and NIH for human research subject protection training. His patient database is strong and Dr. Lassalle is active in patient prescreening as well as study start up and conduct.


Research Team

Clinic Research Coordinator in Orlando, FLNadia A. Sukhraj-Singh – Clinical Research Director

Nadia A Sukhraj-Singh is the Clinical Research Director for Prospira Pain Care and the National Pain Research Institute, LLC (NPRI) corporation.

Nadia has over 10 plus years of experience in the Clinical Research industry. Her research career started at CNS Healthcare as a Regulatory Manager and also has experience as a Clinical Research Coordinator, Clinical Site Manager, Clinical Site Director, Research Project Coordinator, Business Development, and Quality Assurance Auditor. Nadia was the co-Author for her first ABSTRACT Publication Achievement: Effectiveness of Oral Serum Bovine Immunoglobulin in Irritable Bowel Syndrome with Diarrhea Patients in Clinical Practice.

In 2016, Nadia established a research consulting company, Innovative Research Consulting Firm, LLC. As owner and President of Innovative Research Consulting Firm, LLC she wanted to make a difference in the Clinical Research Industry by bringing cutting edge research to local physician practices. She saw that many Research facilities needed guidance and she focused her attention on the research programs by conducting research trials in accordance to GCP and FDA guidelines. Her consulting firm provided the guidance to Research Sites, Physicians and Research staff who desired to improve the process at their sites in a compliant manner. She is also an expert in quality assurance, audits, process improvement, staff training such as PI oversight training, Protocol training, Protocol Amendment training, Regulatory, GCP, NIH, HIPPA, creation of Standard Operation Procedures and Corrective Preventive Action Plans. She has opened two phase I sites, re-structured four Research facilities and managed several research sites during her 10 year research career.

Nadia is a seasoned veteran in the field of clinical research. She comes to Propsira and NPRI, LLC with a wealth of knowledge and experiences in the industry. She has successfully managed a variety of Clinical Research projects to include: Phases I-IV, Investigator Initiated Trials, External Non-Clinical Research Studies, Observational and Registry trials. Her research experience is vast as a research Study Coordinator, Clinical Site Manager, Regulatory Affairs Manager, Budgets, contracts, billing, Site Training, Auditing and Quality Assurance. Nadia clinical experience include IV certification, Advanced cardiac life support, ECG and phlebotomy.


Clinic Research Coordinator in Orlando, FLNicole Coronado, BSN, RN Clinic Research Coordinator

Nicole received her Bachelor’s degree in Psychology from the University of Florida and her Bachelor’s degree in Nursing from the University of Central Florida. She has a passion for clinical trials and has over 8 years of direct clinical experience working with patients of all ages in addition to Phase I-IV clinical studies. She is certified in Good Clinical Practice Guidelines and is an expert in the project management of clinical research trials. She is well experienced in phlebotomy, EKG functions, source creation, Electronic Data Capture systems, patient recruitment, and handling of biohazard materials. As a primary research coordinator for the Winter Park location, she completes site initiation visits, monitoring visits, all patient visits, source creation and total conduction of each protocol. Through her experience, Nicole has become a highly knowledgeable and reliable clinical research coordinator that maintains a supreme quality of work sought out by sponsors.


Other Information

The National Pain Research Institute, LLC, is able to use a central IRB. We have experience with many of the central IRBs: WIRB, Quorum, Schulman, NEIRB, Coast IRB, Aspire IRB, Copernicus and others.

We also have legal counsel who will consult on contract issues, and HIPAA compliance.


Facility Description

Our interdisciplinary site offers multi-therapeutic outpatient care to our patients. Our patients are seen by Board Certified MDs and have the opportunity to have their entire treatment plan carried out in our office.

Our facility has X-ray capabilities as well as ECGs, and phlebotomy. We have infusion therapy for subjects requiring it. In our surgical procedure room we perform cervical and lumbar epidurals, cervical and lumbar Facet injections, flouroscopic guided Radio Frequency Lesioning, nerve blocks, trigger point injections, implantable medication dispensing pump trials, spinal cord stimulation trials and joint injections.

Our Winter Park office is just outside the city of Orlando. We are the largest pain management facility in the Central Florida area. We have direct access to the public transportation system with bus stops right outside our door.

Our Port St. Lucie facility is located directly off of I-95, in the heart of St. Lucie West. It also has easy access to the public transportation system.

Both of our facilities are less than an hour to the nearest international airport.


Description of Current Clinical Studies

Lumbar Disc Herniation

A Study to Evaluate the Long Term Safety of a Medication Called SI-6603 for Patients with a Lumbar Disc Herniation

CATEGORY:
Chronic Pain for patients with lumbar disc herniation (a rupture or protrusion of the disc between the bones of the spine)

PURPOSE:
The purpose of this study is to evaluate how well the drug works and long-term safety of a medication called SI-6603 in patients with a lumbar disc herniation by monitoring the patients for 1 year after the administration of a single dose of the medication.

Patients will receive either an injection of the study drug into the herniated disc or a placebo (a product that has no active part)

Information regarding safety and side effects that may occur will also be collected.

METHOD OF ADMINISTRATION:
Single injection of study medication

INVESTIGATOR:
Cherian Sajan, MD

KEY REQUIREMENTS TO QUALIFY FOR THIS STUDY:
• Must be between 30 and 70 years of age
• Must have been diagnosed with lumbar disc herniation
• Must have pain in only one leg:
• Must have received 6 weeks or more of adequate conservative medication treatment without any improvement of your pain?

LENGTH/DURATION:
Each subject will be asked to visit the clinic on 10 to 11 days over the period of a year. Most visits will take approximately 1 to 3 hours, but the visit when you receive the experimental study treatment may take a full day.

LOCATION:
1693 Lee Road Winter Park, Fl. 32789

COMPENSATION:
Qualified participants may receive up to $500 for time and travel

WHOM TO CONTACT:
Recruitment Department: 407-203-7936


Sciatica

A Study to Evaluate the Level of Pain Relief After a Single Dose of a Medication Called SP-102 for Patients with Lumbosacral Radicular Pain, Otherwise Known as “Sciatica” or “Sciatica Nerve Pain”

CATEGORY:
Chronic Pain for patients who have lumbosacral
radicular pain, otherwise known as “sciatica” or “sciatic nerve pain”.

PURPOSE:
• To compare the pain relief following a single injection of SP-102 to placebo (a product that has no active part)
• To evaluate your ability to do or not do things
• To characterize any change in your symptoms and overall condition
• To evaluate the safety of the SP-102 injection
• Information regarding safety and side effects that may occur will also be collected.

METHOD OF ADMINISTRATION:
Single injection of study medication

INVESTIGATOR:
Cherian Sajan, MD

KEY REQUIREMENTS TO QUALIFY FOR THIS STUDY:
• Must be between 18 and 70 years of age
• Must have been diagnosed with have lumbosacral
radicular pain, otherwise known as “sciatica” or “sciatic nerve pain”
• Must have pain for at least 6 weeks but no more than 9 months

LENGTH/DURATION:
Each subject will be asked to visit the clinic 9 times total over the period 6 months. Most visits will take approximately 1 to 2 hours.

LOCATION:
1693 Lee Road Winter Park, Fl. 32789

COMPENSATION:
Qualified participants may receive up to $450 for time and travel

WHOM TO CONTACT:
Recruitment Department: 407-203-7936


Flexion Study

Patients with Osteoarthritis of the Hip

CATEGORY:
Patients with Osteoarthritis of the hip.

PURPOSE:
• To assess the efficacy of study drug on pain following an intra-articular (IA) injection in patients with hip osteoarthritis (OA).
• To evaluate Study drug on function, global impression of change, stiffness, quality of life, treatment satisfaction, sleep quality and consumption of rescue medication in patients with hip OA.
• To characterize any change in your symptoms and overall condition.
• To evaluate the safety of the assess the overall safety of a second injection.
• Information regarding safety and side effects that may occur will also be collected.

METHOD OF ADMINISTRATION:
• Study drug or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.
• Patients eligible for the second injection in the open-label phase at Week 12 will receive an open-label injection.

INVESTIGATOR:
Cherian Sajan, MD – Principal Investigator
Cesar A. Lassalle-Nieves, MD – Sub-Investigator

KEY REQUIREMENTS TO QUALIFY FOR THIS STUDY:
• Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
• Body Mass Index (BMI) ≤ 40 kg/m2
• Symptoms (including pain) associated with OA of the index hip for ≥ 3 months prior to Screening visit (patient self-report is acceptable). Moderate to severe index hip pain due to OA for >15 days over the last month (as reported by the patient)

LENGTH/DURATION:
Each subject will be asked to visit the clinic 11 times total over the period 9. Most visits will take approximately 1 to 2 hours.

LOCATION:
1693 Lee Road Winter Park, Fl. 32789

COMPENSATION:
Qualified participants may receive up to $975 for time and travel

WHOM TO CONTACT:
Recruitment Department: 407-203-7936


Annular Disc Tears

  • 18yrs and older
  • Single or multilevel lumbar disc tears
  • Prior discography, MRI needed
  • No active litigation related to lumbar pain