Intramuscular injection of botulinim toxin has been shown to be safe and relieves pain associated with several
movement disorders, chronic myofacial and cervical pain syndromes. Increased paraspinal muscle activity has been
implicated as a factor in low back and neck pain. Pain may arise within ischemic overactive muscle itself due to the
build up of metabolic waste products or from structures around the muscle (such as joints and tendons) stressed
by persistent muscle tension. Electroymyographic studies often demonstrate increased electrical activity of the
paraspinal muscles during activity in patients with low back pain compared with subjects without pain. The possibility
that overactive paraspinal muscles may contribute to low back pain provides a rationale for treatment strategies aimed
at reducing paraspinal muscle tone, such as biofeedback and muscle relaxing drugs.
 
There are risks involved in Botulinim injections. Common side effects include muscle weakness that may affect
function of the limb treated, local bruising, and discomfort at the injection site. There are other common side effects
related to the particular disorder that is being treated.
 
The procedure will consist of the following: You will receive botulinum toxin by injection into the muscle through the
skin. The skin will be cleaned with an alcohol pad, and the site may be determined by using a small electric stimulator
that is called an EMG machine. This allows the physician to correctly locate the muscle to inject. A small electric
current may be applied onto the surface of the skin or just beneath the surface of the skin or just beneath the surface
of the skin with a small, sterilized needle. 
 
Botulinum toxin may relieve symptoms for three to six months. You may notice some improvement within the next 72
hours but may not notice anything for up to two weeks. 

Dystonia is a neurologic disorder manifested by involuntary , sustained contractions (spasms) of muscles producing
abnormal postures.  Injections of botulinum toxin type A (Botulinum toxin), a protein that causes temporary weakness
of the injected muscles, may provide effective relief for dystonia, hemifacial spasm ( involuntary twitching of one side
of the face), spasticity and other painful conditions due to involuntary muscle contractions. Studies involving many
patients have demonstrated the safety and effectiveness of this form of  treatment.
 
Botulinum toxin type A, though approved by the FDA for treatment of blepharospasm and hemifacial spasm, has not
been approved in treating dystonias, spasticity, or muscle pain. However, the American Academy of Neurology has
deemed this drug safe and effective in the treatment of oromandibular, cervical, spasmodic, and focal dystonia.  In
addition, the National Institute of Health has also issued a consensus statement that this drug is effective and safe in
treating these disorders.
 
In addition to dystonia, recent clinical reports in the medical literature indicate that botulinum toxin type A treatments
are safe and effective in the treatment of muscle spasticity (involuntary spasms often seen after spinal cord injury,
head injury, and other neurologic disorders). Patients that have had head injuries and strokes often have symptoms
with elements of both spasticity and dystonia.
 
An alternative to botulinum toxin type A therapy would be medications taken by mouth such as diazepam, benztropine,
clonazepam, baclofen, and others.  Additionally, certain physical therapies are known to be beneficial in the disorder as
well.
 
You may be videotaped prior to and while receiving the medication.  By signing this consent form, you give your
permission to have Lynne Carr Columbus, D.O. or her assistants, make photographs, videotapes, and /or recordings of
these injections, under the condition that these photographs, etc., will be used in the interest of medical teaching,
research, or health science. These photographs, tapes or recordings and information relating to your case
may be published and republished in professional journals or medical books.
 
The procedure will consist of the following: You will receive the botulinum toxin type A by injection into the muscle
through the skin.  The skin will be cleaned with an alcohol pad, and the site to be injected may be determined by using
a small electric stimulator that is connected to a battery or a larger machine that is called an EMG machine.  This
allows the physician to correctly localize the proper area of the muscle to inject.  A small electric current may be
applied onto the surface of the skin or just beneath the surface of the skin with a small, sterilized needle.  You will
usually receive three needle sticks to each muscle for even distribution of the drug, and approximately 0.3 ccs of fluid
(less than a teaspoon) will be injected with each needle insertion.
 
Botulinum toxin type A may relieve symptoms for three to six months.  You may notice some improvement within the
next 72 hours but may not notice anything for up to two weeks. If at any time you are uncomfortable during the
procedure, please let us know.
 
Potential benefits of this treatment would include reduction in painful spasms, increased ability to range a joint such as
the ankle, knee, or arm, potential to increase the speed of walking and other functional abilities, and potential for
certain physical therapies to be performed more easily, such as splinting and casting.
 

There are risks involve in botulinum toxin type A injections.  Common side effects include muscle weakness that may
affect function of the limb treated, local bruising, and discomfort at the injection site.  There are other conditions listed
below in which these injections are performed.  The common side effects related to the following disorders and their
treatments include:
 
*For treatment of Blepharospasm ( involuntary eye closing): ptosis ( eyelid drooping),  diplopia (double vision), burning
and pain, eyelid swelling and bruising, tearing.
 
*For treatment of Oromandibular dystonia: dysphasia (swallowing and chewing difficulties), dysarthria (talking
difficulty), hoarseness, drooling.
 
*For treatment of Cervical dystonia: dysphasia, dysarthria, singing difficulty, neck weakness.
 
*For treatment of hemifacial spasm: facial weakness
 
*For treatment of focal dystonia: hand weakness and foot drop
 
Rare side effects have been reported but are not necessarily results of the botulinum toxin. These include: nausea,
muscle soreness headaches, lightheadedness, fever, chills, hypertension, weakness, difficulty breathing, diarrhea, and
abdominal pain.