CLIENT CONSENT FORM
DEPARTMENT OF CLINICAL SCIENCES
1. Title of Research Study:
Equine Foot Pain Rehabilitation Clinical Trial
2. Contacts:
Project
Director: Debra Ruffin Taylor, DVM,
Department of Clinical Sciences, J.T. Vaughan Teaching Hospital 1500 Wire Rd.,
Auburn, AL 36849; email: ruffidc@auburn.edu
Co-investigators: Robert Gillette,
DVM, PhD, Sports Medicine,
John Schumacher,
DVM, Department of Clinical Sciences, J.T. Vaughan Teaching Hospital 1500 Wire
Rd., Auburn, AL 36849; email:
schumjo@auburn.edu
Institutional
Contact: Research Compliance
Specialist, Office of Animal Resources, 307 Samford Hall,
Hospital Review Contact Person:
Questions regarding this study should be directed
to the contact persons listed above.
In the case of a conflict with the study personnel, the attending veterinarians,
owners may contact the following individuals with their concerns.
Doug Allen,
Director, Veterinary Teaching Hospital
Ray Dillon,
Professor, Small Animal Internal Medicine
Chair, Clinical Research Review Committee
3. Purpose of the
Research: Investigation of the hypothesis
that specific trimming and management techniques (Hoof Rehab System) can elicit
physical change in the heel region that is associated with the resolution of
foot pain.
Specific Aims: Document
anatomic and gait changes in horses with forelimb foot pain before and after
treatment with the hoof rehabilitation system.
Criteria: Horse must have a
clinical diagnosis of forelimb foot pain that has been alleviated by a palmar
digital nerve block, performed by the referring veterinarian, for consideration
for this trial. Horses
will be excluded from the study if additional injuries/lameness pre-exist.
Horses must be off all medications for one week prior to day one of the study.
4. Procedures for the
Research: Horses enrolled in this project will be subjected to the following
procedures:
Day1 (or within one
month prior to day 1)
·
Lameness
will be subjectively verified and graded
by Dr. Jennifer Taintor or Dr. John Schumacher with a scale of Walk –
1-10 and Trot 1- 10 as previously described by Wright et al.
·
Kinematic
Gait analysis will be performed to document the degree of lameness, stride
length, hoof landing and stride position in relation to the horse’s trunk.
·
A palmar
digital nerve block will be performed with lidocaine (short acting local
anesthetic) by the examining veterinarian.
The horse will be re-evaluated for lameness and a video will be obtained
of the horse walking and trotting.
o
If the
examiner determines by subjective evaluation that the lameness has been
alleviated by the block, the horse will be admitted into the study.
o
The horse
will be excluded from the study if the this nerve block does not alleviate the
lameness.
·
Radiographs will be obtained: Navicular series – 5 views per foot, to be
obtained as per standard AULAC Radiology protocol by licensed radiology
technician Betty Files. The horse will be restrained with a halter and lead rope
by a veterinary technician or student while radiographs are performed.
If the horse is nervous or uncooperative it may be sedated with Xylazine
(0.25mg/kg
·
Photographs of feet – 5 specific angles with a ruler in view, to be later
analyzed by computer software analysis
·
Hoof
impressions – The front feet of each horse will be wrapped with dental
impression material which will cause no pain or discomfort, after the impression
material polymerizes it will be removed with scissors. The forms will later be
filled with plaster of paris to create an exact replica of hoof for permanent
reference and future comparison to impression made at the end of the study.
·
Kinematic
gait analysis –To prepare the horse for
two-dimensional video analysis, circular retroreflective markers will be placed
on the skin over the moveable joints of the forelimbs as well as on the hoof
capsule. Each horse will be videotaped at the trot over a level asphalt surface
at a constant speed comfortable for the horse. The horses will be filmed using
high speed video equipment. .Data collection will occur on three
collection dates for each horse: Day 1(pre-rehab), at 6 months (during rehab)
and at 12 months (post-rehab)
o
The gait will first be analyzed with the horse
barefoot before any hoof treatment.
o The horse will then be evaluated and trimmed by either Pete Ramey AHA certified trimmer or his apprentice, Jennifer Bowman
o
Kinematic Gait Analysis will be repeated after
the trim with the horse barefoot and also while wearing protective hoof boots.
o The videos of from each collection date will be compared to those from the same horse on the other collection dates. Stride length, stride position in relation to the trunk and landing pattern (toe first, flat or heel first) will be documented.
o Trimming description: The hooves will be trimmed at 3-6 week intervals (based on the specific needs of the horse as determined by Dr. Taylor). The cost of hoof trims and boots will be borne by the owner. The hooves will be bare (to encourage/allow stimulation and development of the internal structures in the back of the foot), except for the use of padded hoof boots for exercise and Equicasts or Easycare Glue-on boots for turnout as needed for the comfort and safety of the horse (The need for these tools will be determined with a team decision by the attending veterinarian, the horse owner, Dr. Taylor and Pete Ramey. The priorities used in hoof trimming will be 1) Horse comfort. 2) Heel first impact and caudal foot stimulation/development. 3) The growing out of any hoof wall separation. [For greater detail: see attached hoof care protocol]
· After trimming, booting and gait analysis is complete, a navicular bursa block will be performed with 5 ml of bupivicaine and 500 mg of Amikacin in order to further characterize the anatomical origin of the lameness.
o
The horse will then return home with the owner.
o Trimming and booting will be continued at 3-6 week intervals to encourage and maintain a comfortable heel first landing. The prescribed boots will be either, Easyboot Gloves, Epics or Glue-ons. (see www.easycareinc.com for complete description of the padded hoof boots
·
The
“at-home” care by the owner will also include the following:
o
Management of central sulcus thrush if present
§
Antibiotic and antifungal ointment to sulcus, applied daily
§
Introduction of pea gravel to stabling environment
o
Dietary management
and mineral supplementation to meet NRC requirements.
o
Initially pasture
rest may be prescribed between trims until heel first landing is achieved.
o
Pea gravel loafing
areas must be provided in areas the horse frequents, such as stalls, watering
areas, shade areas and/or other loafing areas.
o
After heel first
landing is achieved, exercise in hoof boots will be prescribed
o Return visit to the AULAC at 6 months for repeat gait analysis, lateral radiographs, and photographs of the front feet.
o Return visit to the AULAC at 12 months for gait analysis, navicular series radiographs, photographs and hoof impressions.
· Clients will also be responsible for providing daily exercise (preferably 18-24 hour turnout with other horses plus 1-2 hours of riding 3 days a week if possible based on current soundness of horse) and will be expected to maintain an exercise log and make monthly notes on horse’s progress. Monthly notes to include; client assessment of lameness, horse’s willingness to work and the client’s over all satisfaction with the progress
· Clients are also expected to provide a turnout area no smaller than ¼ acre and a pea gravel (1/4 inch diameter stones) foot conditioning area at least 12’ x 12’ x 4” deep.
·
Phenylbutazone administration will be allowed
prior to exercise (4 mg/kg per day orally) if needed for pain relief, during
rehab. A log of phenylbutazone usage
must be kept and horses must be off phenylbutazone 10 days prior to all
re-checks.
·
The principal investigator has the right to
withdraw a horse from the study due to lack of owner cooperation or compliance
to protocol.
5. Potential Risks or
Discomforts: As with any veterinary examination of the equine species, accidental
injury could occur due to unforeseen circumstances.
Every effort will be taken to insure the safety of the horses with in the
study while on the Auburn University
6. Potential Benefits:
The client will help us document and understand the effects of the Hoof Rehab,
hoof rehabilitation system. This
study has the potential to ameliorate hoof pain in the horses within the study
as well as demonstrate the effects of this system to the scientific community.
If the scientific community begins to understand and accept this
rehabilitation process as a treatment alternative for horses with heel pain,
countless other horses may be helped in the future.
7. Alternative Treatments
or Procedures, if applicable:
The clients will be offered traditional
treatments for foot pain and may choose at their will if they would like to
participate in this study, or pursue a more traditional approach of therapeutic
shoeing and anti-inflammatory drug therapy.
8.
Financial Considerations for Participation in the Study:
The client will be responsible to pay for the following:
Initial diagnosis of foot pain by
referring veterinarian
pre-rehabilitation radiographs
$185
hoof trims
$60 each
hoof boots
$100 per pair
+/- Equicasts or Glue-on boots
$50 per pair
The client will not be charged for the following:
lameness examinations at AULAC
radiographs at 6 and 12 months
digital photographs
kinematic gait analysis
hoof impressions
navicular bursa anesthetic injection
and post-treatment radiographs.
9.
Additional Expenses Expected for Participation in the Study:
Thrush treatment medication if needed
$20 per month
Mineral supplement
$60 per month
Pea Gravel Loafing areas
$100 – 300 (depending
on delivery)
Fuel costs to return horse to AULAC for foot trims or
board in
Fuel costs to return the horse to
the AULAC for rechecks at 6 and 12 months
10. Client
Consent
Owner Assurances:
a. I understand that I am free to withdraw my consent and discontinue participation in this research project at any time without this decision affecting my animal’s future and continued medical care by the AU Veterinary Teaching Hospital.
b. I understand the decision to withdraw from the study or to disregard the recommendations of the veterinarians involved in the study, relieves the investigators of all current and future responsibilities and commitments (both medical and financial) to the horse and/or the owner.
c. I understand I am responsible for all treatments sought or required by my horse at AUVTH or at any other veterinary facility.
d. I understand that if I withdraw from the study, I am accepting responsibility for medical and diagnostic costs incurred that may have been initially covered by the study.
a. I understand that my decision to discontinue participation in this study, whether to pursue other therapies or to have my horse euthanized, does not entitle me to any financial reimbursement for costs incurred during participation.
b. I understand that I must notify either Dr. Debra Taylor or Dr. Doug Allen if I decide to discontinue participation in the study.
e.
I also understand that
11.
SIGNATURES
I have
fully explained to ___________________________________ the nature and purpose of
the above-described procedure and the benefits and risks that are involved in
its performance. I have answered and will answer all questions to the best of my
ability. I may be contacted at the following telephone number:
_________________.
___________________________________ _____________________
Signature of
Principal or Co-Principal Date
Investigator
Obtaining Consent
I have been
fully informed of the above-described procedure with its possible benefits and
risks and I have received a copy of this description. I certify that I am the
legal owner (or agent of the owner) of, and am responsible for, this animal. I
permit my animal’s participation in this study.
___________________________________
Animal ID
___________________________________ _____________________
Signature of
Client Date
___________________________________
Street
Address of Client
___________________________________
City, Zip