Clinical Trial

Study to evaluate the effectiveness of a novel pain modulator for the control of elbow pain in dogs

Department: Orthopedics Service

Overview

Title:
An exploratory field study to investigate the safety and effectiveness of concomitant intra-articular (IA) and peri-neural (PN) injections of a novel pain modulator for the control of elbow pain in dogs

Investigators:
Steven Budsberg, DVM, MS, DACVS (Surgery Faculty – Orthopedics)
Valentine Verpaalen, DVM, MS, DACVS (Surgery Faculty – Orthopedics)
Whitney Hinson, DVM, MS. DACVS (Surgery Faculty – Orthopedics)

If interested, please call the Clinical Trials Coordinator Lisa Reno at 706-296-7818.

Study Description:
For veterinary patients suffering from osteoarthritis associated pain, currently available treatments may lack effectiveness, or be associated with adverse effects if used for extended periods of time. Recent studies have shown that a novel, naturally occurring compound that is highly selective for pain nerves, may have the potential to control chronic pain without affecting nerves responsible for transmitting sensations of touch, pressure, vibration, muscle control, or cognition. The objective of this pilot study is to assess the effectiveness and safety of this pain modulator in dogs with elbow pain.

Inclusion Criteria:

  • Dogs of any breed or sex, at least 1 yr. old and weighing at least 15 kg
  • Joint pain must originate from the elbow; elbow must be only joint of that limb showing pain.
  • History of persistent lameness due to elbow pain for at least 2 months prior to enrollment

Exclusion Criteria:

  • No NSAIDs, analgesics, or other treatment for osteoarthtiris in preceding 10 days
  • No CBD oil, short and long-acting corticostaroids, or injectable polysuphated glycosaminoglycans (Adequan®) within the preceding 30 days
  • No unmanaged systemic disease, or local disease other than osteoarthritis of the elbows
  • No elbow joint instability, intra or peri-articular tumors, or unhealed fractures
  • No medical or surgical procedure (including acupuncture, laser therapy, intra-articular joint injections) within the preceding 4 months

Dogs with arthritis associated pain of the elbow and meeting the above criteria will receive a baseline evaluation that includes the following: physical, orthopedic, and lameness examinations by a board-certified veterinary surgeon, and gait analysis, Dogs eligible for enrollment will be randomly assigned to one of two treatment groups: dogs that receive the pain modulator injected into the elbow joint and around the nerve leading to that joint, and dogs that receive a sham (saline) injection. Dogs that have been assigned to the placebo group initially will have the option of receiving the pain modulator upon study completion. On Day 0 of the study, dogs will be placed under general anesthesia for administration of the assigned treatment. Dogs will be recovered from anesthesia and monitored for 4 hours before discharge from the hospital. Follow up appointments will be scheduled on Day 7, Day 28, Day 90 and 6 months after treatment, and will include orthopedic and force plate evaluation. Throughout the study owners will be asked to fill out a daily observation survey and weekly behavioral assessments. All procedures described above will be paid for by the study. Costs for any adverse events related to study procedures will also be paid by study funds. Dogs that have been assigned to the placebo group initially will be invited to receive the pain treatment and re-enter the study, with all study procedures paid for by study funds.

Potential Benefits to Veterinary Medicine:
Accurately assessing the efficacy of a new pain modulator may provide a promising alternative to chronic painful conditions such as osteoarthritis.