Helping to Advance Companion Animal Pain Management and Anesthesia
A clinical investigation is also referred to as a clinical trial. A clinical investigation is a study with animals (volunteered by their owners) to help answer specific health questions. Peak Performance Veterinary Group’s “volunteer” animals are comprised predominantly of the patients receiving care in our clinic. Some patients are also recruited from other veterinary practices and organizations. Carefully conducted clinical investigations are the safest and fastest way to find new and improved treatments that work to increase pain control and anesthesia safety.
Our goal and primary focus in conducting clinical investigations is to assist with the development and advancement of new therapies in every aspect of companion animal pain management and anesthesia.
Patient / Owner Benefit
Patients often benefit from participation in clinical investigations by receiving innovative treatment modalities, thus potentially increasing their pain control or safety under anesthesia. Owners benefit by receiving free diagnostic testing, free therapies and often, some small compensation for their time and effort.
Before joining a clinical investigation, a patient must qualify for the study. Each study has its own set of criteria. Owners must be willing to come back periodically for follow up care and evaluation of their pets. Owners, with pets in studies, play a more active role in their pet’s health care, gain access to new treatments before they are widely available, and can help other pets.
Our Research History
Peak Performance Veterinary Group (formerly Animal Anesthesia and Pain Management Center) has been conducting clinical trials in Colorado Springs since 2003. Additionally, Dr. Gaynor has been involved in clinical trials since 2004. We are the only pain management / anesthesia practice in the Pikes Peak region dedicating significant amounts of time and resources to this important endeavor. Our trials and investigations are sponsored by a variety of organizations, including pharmaceutical and device / equipment companies.
If you are interested in having your pet participate in a research study, please call us at 719-330-5608. Our staff can inform you if we are currently conducting an investigation that would be beneficial to your pet’s needs.
There are currently 2 funded trials listed below
A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH OSTEOARTHRITIS
This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with osteoarthritis. The drug is administered as one-time intra-articular injections in 1 or 2 joints. The injection will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 15 client-owned dogs with osteoarthritis will be enrolled. Owners will be required to complete pain assessment surveys, track their dog’s activity through the use of an activity monitor worn on the dog’s collar, and record short at-home videos assessing the dog’s gait. The trial site will train the owners on all of these assessments. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84. Medications targeted at the treatment of osteoarthritis associated pain are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study.
The trial is fully funded for the full trial duration (84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 4 months of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to the trial.
Dogs are eligible if they meet the following inclusion criteria:
- Dog’s body weight 10-50 kg
- Dog has clinical signs and radiographic evidence of osteoarthritis in one or multiple joins
- Dog is experiencing osteoarthritis pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments
Dogs are not eligible if they meet any of the following exclusion criteria:
- Dog has a life expectancy of < 3 months
- Dog has any underlying disease that will affect the study objectives or patient safety
- Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
- Dog is impaired due to neurological disease or other orthopedic disease
- Dog is pregnant or lactating
- Dog is participating in another study
- Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
- Dog requires medications or supplements during the course of the study that interfere with the objectives of the study
ASSISI LOOP® STUDY
Thank you for your interest in our clinical investigation using the Assisi Loop®. This is a non-invasive, targeted pulsed electromagnetic field therapy device with a tremendous amount of data related to pain control and healing in humans and laboratory animals. There are no known side effects associated with it s use.
This is a 21 day, double-blinded, placebo-controlled study investigating the effectiveness of the Assisi Loop® for the treatment of lameness and pain in dogs with osteoarthritis. Dogs who are assigned to the placebo group will receive the true device for treatment at the end of the study.