INTERVERTEBRAL DISC DISEASE CLINICAL STUDY

INTERVERTEBRAL DISC DISEASE CLINICAL STUDY

Postby THELOSMAN » Mon Oct 11, 2010 7:57 pm

VALLEY CENTRAL VETERINARY REFERRAL HOSPITAL HAS A CALL FOR CASES!!!!
CLINICAL TRIAL IN DOGS WITH ACUTE DISC HERNIATION

VCVRH is collaborating with NCSU veterinary school in a clinical trial comparing placebo, high doses of steroid therapy and polyethylene glycol in dogs that are deep pain negative and have surgery. It is expected that steroid therapy will make no difference in outcome and make some dogs sick while polyethylene glycol might help some dogs to recover. We do not advise therapy with high doses of steroid.

We are seeking patients who:
-Have acute onset hind limb paraplegia and no deep pain likely due to an acute disc herniation.
-Are between 2 and 10 years of age and less than 20kg.
-Have not received steroids or multiple NSAID doses before referral.

These patients may be eligible for inclusion in a multi-center trial seeking to evaluate the effectiveness of adjunctive medical treatment of patients who undergo decompressive surgery. Eligible patients will receive study medications and rechecks at no charge. Clients will be responsible for the costs of diagnostics and surgery at a reduced cost. The study is funded by the Morris Animal Foundation. Please see the below for a full explanation of the study.

The following is an overview of what your clients can expect if entered into the study;

Severe acute intervertebral disc herniations (IVDD) are a common problem in dogs currently treated by surgical decompression of the spinal cord. However, there is a lot of controversy as to whether adjunctive medical therapy is also beneficial. The two drugs that are advocated for use are a high dose regimen of methylprednisolone sodium succinate (MPSS) and a relatively new drug called polyethylene glycol (PEG).

This blinded, prospective clinical trial will compare MPSS, PEG, and saline placebo as adjunctive medical therapies to surgical decompression in dogs with acute intervertebral disc herniations. The data generated will represent the first objective information on the medical management of acute disc herniations in dogs. We hope to resolve the controversies surrounding the medical treatment of this common disease and to improve the outcomes for our patients.

The dogs included in the study are between two and ten years old and weight less than 20kg. They have to be paraplegic for duration of 24 hours or less with no deep pain sensation in the pelvic limbs and no history of systemic illness that would preclude the use of high doses of MPSS. Patients should be excluded if they have received more than two appropriate doses of any NSAID or steroid medication in the previous 48 hours. They MUST have decompressive surgery to be eligible for the study. The owner must be willing to return to the hospital for scheduled rechecks at 2, 4, 8, and 12 weeks after discharge.

Patients who are admitted to the study will initially have a neurologic exam and videotaping prior to having diagnostics performed to confirm a disc herniation. Administration of the study medication (a bolus followed by a 24 hour continuous rate infusion with a second bolus at 4 hours) will be started once the diagnosis has been confirmed and will continue during surgery. Each of the 3 therapies (MPSS, PEG and placebo) will be prepared to appear identical and will be assigned to patients in a random order. The identity of the medication will be unknown to the veterinarians and the dog owners. Following surgery, the patient will be recovered from anesthesia and the 24-hour drug infusion will be completed. In addition, all dogs will receive gastrointestinal protectants both because of the high incidence of gastrointestinal irritation in dogs with disc herniations, and because they may have been treated with MPSS. Post operative care will follow normal protocols including administration of pain medications as needed. Twenty-four hours after admission, the neurologic exam and videotaping will be repeated.

Patients will be discharged when the attending clinician feels it is appropriate in consultation with the owner. Dogs will return for repeat videotaped neurological examinations at 2, 4, 8, and 12 weeks after surgery. In between appointments, the owners will be asked to fill out a short questionnaire. If at any time the patient suffers any adverse event, whether or not it is likely to be associated with one of the test drugs, it will be reported. In the case of severe complications, the study safety monitor may request the identity of the drug administered from the pharmacists.

For more information, please refer to the study website: http://cvm.ncsu.edu/vth/clinical_servic ... _disc.html

For questions, please contact:
Becky Remaly, CVT
610-435-1553 ext. 122
becky@vcvrh.com
THELOSMAN
 
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