Safety and Effectiveness of Long-Acting Intra-Articular and Peri-Neural Injections for the Management of Elbow Pain in Dogs
OpenThis is an exploratory study to evaluate the safety and effectiveness of concomitant intraarticular (IA) and peri-neural (PN) injections of an investigational veterinary product for the control of elbow pain in dogs. This 28-day study also includes a long term follow up at 3 and 6 months. This study involves a one-time injectable treatment with investigational product under general anesthesia or sedation. This study does include a control group. An estimated 20 client-owned dogs will be enrolled. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to dog’s pain level throughout the study. Study visits include the dog’s initial consultation, treatment Day 0, recheck visits on Day 7, 28, 90, and 180. The study is fully funded for the entire duration of 28 days including the 3 and 6 month follow up visits. Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.
ELIGIBILITY CRITERIA
- Any dog in general good health or with stabilized chronic conditions
- Older than 1 year of age
- Weighs ≥15 kg
- Has clinically documented articular pain originating in at least one elbow and the only joint on that limb to show signs of pain
- Has history of persistent lameness due to elbow pain for at least 2 months prior to enrollment
- Any medication used for the treatment of pain has been discontinued at least 10 days prior to screening
- No elbow pain due to recent trauma (<2 months), unhealed fractures, intra-articular/peri-neural tumors, or active immune-mediated joint disease
- No medical/surgical procedure on affected joint within 120 days of study enrollment
PARTICIPATING HOSPITALS
- Veterinary Specialty Hospital, Sorrento Valley, San Diego, CA